FDA.reportPublic FDA data

Nalbuphine hydrochloride

Product NDC
70069-671
11-digit product format
700690671
Labeler code
70069
Product ID
70069-671_d7e3d7be-ce38-4696-979c-64dd1023a4cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nalbuphine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA216050
Marketing category
ANDA
Marketing start
2024-09-25
Substance
NALBUPHINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nalbuphine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALBUPHINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZU4275277R
Rxcui1866543, 1866551

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e665fab2-f6df-99b6-a22d-5d9276f14b80Product name320250331

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-671-01Nalbuphine hydrochloride1 mL in 1 AMPULEINJECTION16
70069-671-10Nalbuphine hydrochloride10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-671-01ML - Milliliter70069-67177aa1b26-fc26-4b0f-af8d-ba7e23091b9812024-10-04
70069-671-10ML - Milliliter70069-6719f623e69-6403-4c25-91a7-31aba425ddac12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-671NALBUPHINE HYDROCHLORIDE INJECTION [SOMERSET THERAPEUTICS, LLC]6Current NDC, 2 package rows20250504_a3221c05-5822-4ab8-b589-0e3939b91a68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1866543nalbuphine HCl 10 MG in 1 ML InjectionPSNa3221c05-5822-4ab8-b589-0e3939b91a686
1866551nalbuphine HCl 20 MG in 1 ML InjectionPSNa3221c05-5822-4ab8-b589-0e3939b91a686
18665431 ML nalbuphine hydrochloride 10 MG/ML InjectionSCDa3221c05-5822-4ab8-b589-0e3939b91a686
18665511 ML nalbuphine hydrochloride 20 MG/ML InjectionSCDa3221c05-5822-4ab8-b589-0e3939b91a686
1866543nalbuphine HCl 10 MG per 1 ML InjectionSYa3221c05-5822-4ab8-b589-0e3939b91a686
1866551nalbuphine HCl 20 MG per 1 ML InjectionSYa3221c05-5822-4ab8-b589-0e3939b91a686

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-671-01700690671011 mL in 1 AMPULE1 mlHistorical
70069-671-107006906711010 AMPULE in 1 CARTON (70069-671-10) / 1 mL in 1 AMPULE (70069-671-01) 10 ampule2024-09-25NoNoCurrent