Home NDC 51662-1418 NALBUPHINE HCI
Product NDC 51662-1418
11-digit product format 516621418
Labeler code 51662
Product ID 51662-1418_2b37c24d-1ab8-34d6-e063-6294a90abf70
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NALBUPHINE HCI
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA070918
Marketing category ANDA
Marketing start 2019-10-29
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 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 A070918-001 NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/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 A070918-001 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 A070918-001 NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A070918-001 NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070918-001 NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070918-001 NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070918-001 NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070918-001 NALBUPHINE HYDROCHLORIDE 20MG/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 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 51662-1418-1 NALBUPHINE HCI 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 4 51662-1418-1 NALBUPHINE HCI 1 in 1 CARTON INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1418 NALBUPHINE HCI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 4 Current NDC, Legacy NDC, 2 package rows 20250110_96128b54-24d6-88a3-e053-2a95a90a1c9c.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 · 3 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): 070918 application number: ANDA070918 NALBUPHINE HCI NALBUPHINE HCI HF Acquisition Co LLC, DBA HealthFirst 96128b54-24d6-88a3-e053-2a95a90a1c9c 2025-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070918 application number: ANDA070918 ndc (product): 51662-1418 Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE Medical Purchasing Solutions, LLC 28f274a4-62c4-4e54-e063-6394a90a2200 2024-12-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070918 application number: ANDA070918
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 51662-1418-1 51662141801 1 VIAL, MULTI-DOSE in 1 CARTON (51662-1418-1) / 10 mL in 1 VIAL, MULTI-DOSE 2019-10-29 0000-00-00 No No Current