Home NDC 0404-9766 Nalbuphine Hydrochloride
Product NDC 0404-9766
11-digit product format 004049766
Labeler code 0404
Product ID 0404-9766_2d21ad96-ce58-4576-8460-bcc3265e668d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nalbuphine hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Henry Schein, Inc.
Application ANDA216049
Marketing category ANDA
Marketing start 2025-12-10
Substance NALBUPHINE HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216049-001 NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 A216049-002 NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A216049-001 NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216049-002 NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216049-001 NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216049-002 NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216049-001 NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216049-002 NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216049-001 NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216049-002 NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216049-001 NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216049-002 NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216049-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-09-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216049-002 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2024-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216049-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-09-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216049-002 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2024-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216049-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-09-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216049-002 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2024-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216049-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-09-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216049-002 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2024-09-19 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216049-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-09-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216049-002 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2024-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216049-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-09-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216049-002 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2024-09-19 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216049-001 NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216049-002 NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2024-09-19 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216049-001 CGT 2025-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216049-002 CGT 2025-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216049-001 CGT 2025-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216049-002 CGT 2025-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216049-001 CGT 2025-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216049-002 CGT 2025-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216049-001 CGT 2025-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216049-002 CGT 2025-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216049-001 CGT 2025-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216049-002 CGT 2025-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216049-001 CGT 2025-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216049-002 CGT 2025-03-30 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216049-001 CGT 2025-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216049-002 CGT 2025-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216049-001 CGT 2025-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216049-002 CGT 2025-03-30 d06236e962d9…
Additional Listing Data#
Finished product Yes
Brand name base Nalbuphine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NALBUPHINE HYDROCHLORIDE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZU4275277R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 904440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0404-9766-10 Nalbuphine Hydrochloride 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 2 0404-9766-10 Nalbuphine Hydrochloride 1 in 1 BAG INJECTION 1 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE Henry Schein, Inc. dd621bfa-ce48-4c27-b247-a6d885f70b72 2026-04-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216049 application number: ANDA216049 ndc (product): 0404-9766 Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE Henry Schein, Inc. 4ef2c0dc-3ab4-4bb1-aff0-523e3c23ad2d 2026-04-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216049 application number: ANDA216049 Nalbuphine hydrochloride NALBUPHINE HYDROCHLORIDE Medical Purchasing Solutions, LLC 292b0d0e-f222-d384-e063-6394a90acd44 2024-12-13 Boxed warning, Adverse reactions Exact identifier application applno (ANDA): 216049 application number: ANDA216049 Nalbuphine hydrochloride NALBUPHINE HYDROCHLORIDE Somerset Therapeutics, LLC d82dafac-cce7-445a-8127-2a10b6d947ca 2024-09-26 Boxed warning, Adverse reactions Exact identifier application applno (ANDA): 216049 application number: ANDA216049
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0404-9766-10 00404976610 1 VIAL, MULTI-DOSE in 1 BAG (0404-9766-10) / 10 mL in 1 VIAL, MULTI-DOSE 2025-12-10 No No Current