Home NDC 0404-9918 Nalbuphine Hydrochloride
Product NDC 0404-9918
11-digit product format 004049918
Labeler code 0404
Product ID 0404-9918_0e0e0bdd-27ee-48e6-9390-56ec6e71eccc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nalbuphine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Henry Schein, Inc.
Application ANDA070914
Marketing category ANDA
Marketing start 2022-01-13
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 A070914-001 NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML (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 A070914-001 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 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML (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 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML (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 A070914-001 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 A070914-001 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 A070914-001 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 A070914-001 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 A070914-001 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 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070914-001 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 A070914-001 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 A070914-001 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 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070914-001 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 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070914-001 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 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070914-001 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 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070914-001 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 A070914-001 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 A070914-001 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 A070914-001 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 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070914-001 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 A070914-001 NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070914-001 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 Hydrochloride
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 1866543 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 0404-9918-01 Nalbuphine Hydrochloride 1 in 1 BAG INJECTION, SOLUTION 1 5 0404-9918-01 Nalbuphine Hydrochloride 1 mL in 1 AMPULE INJECTION, SOLUTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9918 NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20250523_596826ff-e471-4d4f-9a73-2a34e2af2dd6.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. a99fe500-f52b-483c-807c-178f1a78a02b 2026-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070914 application number: ANDA070914 Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE Hospira, Inc. 6025e8d4-5083-4c3a-58a0-050e7b0b6150 2025-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070914 application number: ANDA070914 Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE Henry Schein, Inc. 596826ff-e471-4d4f-9a73-2a34e2af2dd6 2025-05-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070914 application number: ANDA070914 ndc (product): 0404-9918
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0404-9918-01 00404991801 1 AMPULE in 1 BAG (0404-9918-01) / 1 mL in 1 AMPULE 1 ampule 2022-01-13 0000-00-00 No No Current