Home NDC 0409-1464 Nalbuphine Hydrochloride
Product NDC 0409-1464
11-digit product format 004091464
Labeler code 0409
Product ID 0409-1464_cbcbf107-67c0-4a8a-a25d-5a05c43a0bfd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NALBUPHINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hospira, Inc.
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 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 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 904415 Internal RxNorm lookup 904440 Internal RxNorm lookup 1866543 Internal RxNorm lookup 1866551 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 0409-1464-01 Nalbuphine Hydrochloride 25 in 1 CASE INJECTION, SOLUTION 25 34 0409-1464-61 Nalbuphine Hydrochloride 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 34 0409-1464-61 Nalbuphine Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 34
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NALBUPHINE HYDROCHLORIDE ACTIVE INGREDIENT ZU4275277R NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 NALBUPHINE ACTIVE MOIETY L2T84IQI2K NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 WATER INACTIVE INGREDIENT 059QF0KO0R NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1464 NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 33 Current NDC, Legacy NDC, 3 package rows 20241207_6025e8d4-5083-4c3a-58a0-050e7b0b6150.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 ndc (product): 0409-1464 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 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 Units Marketing start Marketing end Sample Exclude flag Status 0409-1464-01 00409146401 25 CARTON in 1 CASE (0409-1464-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1464-61) / 10 mL in 1 VIAL, MULTI-DOSE 25 carton 2005-07-19 0000-00-00 No No Current 0409-1464-61 00409146461 10 mL in 1 VIAL, MULTI-DOSE 10 ml Historical