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PEPLUX

FDA compounding status

Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)

Also listed as NADH, Reduced nicotinamide adenine dinucleotide.

FDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.

NADH is in FDA's 503A Category 1. FDA is still evaluating it and has said it does not intend to take action against a 503A pharmacy that compounds it against a patient-specific prescription while the interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. NADH is not in any 503B category, so a 503B outsourcing facility has no route for it. Compounded NADH is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.

NADH is the reduced form of NAD+. It has its own FDA entry and its own status record, and its status does not transfer to NAD+.

Checked against the primary sources on .

The record

FDA status
FDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.
Compounding basis
503A pharmacy (Category 1, interim policy)Compounded by a state-licensed 503A pharmacy against a patient-specific prescription. The substance is in FDA's 503A Category 1: FDA has said it does not intend to take action while the substance is under evaluation, if the interim policy's conditions are met. This is enforcement discretion, not the bulks list.
FDA advisory committee
Not reviewed
Sport (WADA 2026)
Not named on the WADA 2026 Prohibited List.
Offered by PEPLUX
No
Checked on

Basis

What this status traces to.

FDA's 503A categories document (updated May 14, 2026) lists "Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)" in Category 1, bulk drug substances under evaluation. NADH does not appear in any category of FDA's 503B categories document (updated March 21, 2025). It is not on the 503A bulks list in 21 CFR 216.23. Category 1 is FDA's interim enforcement discretion, not a statutory pathway.

Primary sources

  1. FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
  2. FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .
  3. FDABulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActDocument dated . Checked .
  4. eCFR21 CFR 216.23, Bulk drug substances that can be used to compound drug productsDocument dated . Checked .
  5. FDACompounding and the FDA: Questions and AnswersDocument dated . Checked .
  6. WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .

Context

A removal or a committee vote is not a listing.

Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.

FDA advisory committee

FDA's Pharmacy Compounding Advisory Committee has not reviewed it.

If you are subject to anti-doping rules

Not named on the WADA 2026 Prohibited List.

World Anti-Doping Code, 2026 Prohibited List (dated )

Pending or unconfirmed

FDA's database of approved drugs (Drugs@FDA) has not yet been checked for an approved product containing NADH.

Common questions

Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH), answered plainly.

What is the FDA compounding status of Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)?
NADH is in FDA's 503A Category 1. FDA is still evaluating it and has said it does not intend to take action against a 503A pharmacy that compounds it against a patient-specific prescription while the interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. NADH is not in any 503B category, so a 503B outsourcing facility has no route for it. Compounded NADH is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.
What does the status of Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH) trace to?
FDA's 503A categories document (updated May 14, 2026) lists "Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)" in Category 1, bulk drug substances under evaluation. NADH does not appear in any category of FDA's 503B categories document (updated March 21, 2025). It is not on the 503A bulks list in 21 CFR 216.23. Category 1 is FDA's interim enforcement discretion, not a statutory pathway. Checked against the primary sources on October 13, 2026.
Does PEPLUX offer Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)?
PEPLUX does not currently offer Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH). This page explains its regulatory status and is not a recommendation to use it.
Is Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH) prohibited in sport?
Not named on the WADA 2026 Prohibited List.
Is anything about the status of Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH) pending or unconfirmed?
FDA's database of approved drugs (Drugs@FDA) has not yet been checked for an approved product containing NADH.

Same FDA status

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