Home NDC 51662-1420 NALBUPHINE HCI
Product NDC 51662-1420
11-digit product format 516621420
Labeler code 51662
Product ID 51662-1420_2b37c789-d5da-dc83-e063-6294a90a4ca5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NALBUPHINE HCI
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA070915
Marketing category ANDA
Marketing start 2019-10-29
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070915-001 NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070915-001 AP
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.
Product history page 1 of 2 · 43 observed 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 A070915-001 NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A070915-001 NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070915-001 NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070915-001 NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070915-001 NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070915-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Additional Listing Data#
Finished product Yes
Brand name base NALBUPHINE HCI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NALBUPHINE HYDROCHLORIDE 10 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 904415 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 51662-1420-1 NALBUPHINE HCI 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 3 51662-1420-1 NALBUPHINE HCI 1 in 1 CARTON INJECTION, SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1420 NALBUPHINE HCI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 3 Current NDC, Legacy NDC, 2 package rows 20250110_96139914-0708-7b58-e053-2995a90a7308.zip
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 Hospira, Inc. 6025e8d4-5083-4c3a-58a0-050e7b0b6150 2025-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070915 application number: ANDA070915 Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE ProPharma Distribution 38569b5f-fb37-135e-e063-6294a90a54df 2025-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070915 application number: ANDA070915 NALBUPHINE HCI NALBUPHINE HCI HF Acquisition Co LLC, DBA HealthFirst 96139914-0708-7b58-e053-2995a90a7308 2025-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070915 application number: ANDA070915 ndc (product): 51662-1420 Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE Medical Purchasing Solutions, LLC 6bde2184-5643-3ec6-e053-2991aa0a115f 2023-05-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070915 application number: ANDA070915
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51662-1420-1 51662142001 1 VIAL, MULTI-DOSE in 1 CARTON (51662-1420-1) / 10 mL in 1 VIAL, MULTI-DOSE 2019-10-29 0000-00-00 No No Current