FDA.reportPublic FDA data

Nalbuphine hydrochloride

Product NDC
70069-661
11-digit product format
700690661
Labeler code
70069
Product ID
70069-661_d4c32b91-24cf-43f2-a1d2-0120f31bbba8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nalbuphine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA216049
Marketing category
ANDA
Marketing start
2024-09-26
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
Rxcui904415, 904440

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e665fab2-f6df-99b6-a22d-5d9276f14b80Product name320250331
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-661-10Nalbuphine hydrochloride1 in 1 CARTONINJECTION11
70069-661-10Nalbuphine hydrochloride10 mL in 1 VIAL, MULTI-DOSEINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-661-10ML - Milliliter70069-661aa517da1-588a-4154-aafd-9c4a20084a1d12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-661NALBUPHINE HYDROCHLORIDE INJECTION [SOMERSET THERAPEUTICS, LLC]1Current NDC, 2 package rows20240927_d82dafac-cce7-445a-8127-2a10b6d947ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904415nalbuphine HCl 10 MG/ML Injectable SolutionPSN4ef2c0dc-3ab4-4bb1-aff0-523e3c23ad2d2
904415nalbuphine hydrochloride 10 MG/ML Injectable SolutionSCD4ef2c0dc-3ab4-4bb1-aff0-523e3c23ad2d2
904415nalbuphine HCl 10 MG/ML Injectable SolutionPSN292b0d0e-f222-d384-e063-6394a90acd441
904415nalbuphine HCl 10 MG/ML Injectable SolutionPSNd82dafac-cce7-445a-8127-2a10b6d947ca1
904440nalbuphine HCl 20 MG/ML Injectable SolutionPSNd82dafac-cce7-445a-8127-2a10b6d947ca1
904415nalbuphine hydrochloride 10 MG/ML Injectable SolutionSCD292b0d0e-f222-d384-e063-6394a90acd441
904415nalbuphine hydrochloride 10 MG/ML Injectable SolutionSCDd82dafac-cce7-445a-8127-2a10b6d947ca1
904440nalbuphine hydrochloride 20 MG/ML Injectable SolutionSCDd82dafac-cce7-445a-8127-2a10b6d947ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70069-661-10700690661101 VIAL, MULTI-DOSE in 1 CARTON (70069-661-10) / 10 mL in 1 VIAL, MULTI-DOSE2024-09-26NoNoCurrent