Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Somerset Therapeutics, LLC
079947873
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Somerset Therapeutics Private Limited
Somerset Therapeutics, LLC
Somerset Therapeutics, LLC
677236695
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nalbuphine hydrochloride
Product Details
NDC Product Code
70069-671Application Number
ANDA216050Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSEffective Date
March 26, 2025NalbuphineActive
Code: ZU4275277RClass: ACTIBQuantity: 10 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Nalbuphine hydrochloride
Product Details
NDC Product Code
70069-672Application Number
ANDA216050Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSEffective Date
March 26, 2025NalbuphineActive
Code: ZU4275277RClass: ACTIBQuantity: 20 mg in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT