21922-019 : Testosterone Gel, 1% Gel, 1% 10 mg/g Transdermal Gel


NDC21922-019
Labeler: Encube Ethicals Private Limited
Product Type: Human Prescription Drug
Drug Name:  Testosterone Gel, 1%
Dosage Form: Transdermal Gel
Application #: ANDA212984
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 21922-019-02: 30 PACKET IN 1 CARTON (21922‑019‑02) > 5 G IN 1 PACKET
  • 21922-019-47: 2 CONTAINER IN 1 CARTON (21922‑019‑47) / 75 G IN 1 CONTAINER
  • 21922-019-52: 30 PACKET IN 1 CARTON (21922‑019‑52) / 25 G IN 1 PACKET

Active Ingredients:

  • Testosterone

Dosage Strength:

  • 10 mg/g

Pharmaceutical Classes:

  • Androgen Receptor Agonists [MoA]
  • Androgen [EPC]
  • Androstanes [CS]

Related Products:

Based on records with the same trade name.
  • 63629-9585 Testosterone Gel, 1% Gel, 1% 10 mg/g Transdermal Gel by Bryant Ranch Prepack

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.