Nalbuphine Hydrochloride

Product NDC
71872-7114
11-digit product format
718727114
Labeler code
71872
Product ID
71872-7114_fc5e0914-3e38-0be4-e053-6394a90aee7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NALBUPHINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA070915
Marketing category
ANDA
Marketing start
2005-07-19
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

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
71872-7114-1Nalbuphine Hydrochloride10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION103
71872-7114-1Nalbuphine Hydrochloride1 in 1 BAGINJECTION, SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7114NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]3Current NDC, Legacy NDC, 2 package rows20230524_6bde2184-5643-3ec6-e053-2991aa0a115f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904415nalbuphine HCl 10 MG/ML Injectable SolutionPSN6bde2184-5643-3ec6-e053-2991aa0a115f3
904415nalbuphine hydrochloride 10 MG/ML Injectable SolutionSCD6bde2184-5643-3ec6-e053-2991aa0a115f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7114-1718727114011 VIAL, MULTI-DOSE in 1 BAG (71872-7114-1) / 10 mL in 1 VIAL, MULTI-DOSE2018-05-030000-00-00NoNoCurrent