Home NDC 0409-1465-01 Nalbuphine Hydrochloride
Product NDC 0409-1465
Requested package NDC 0409-1465-01
11-digit product format 004091465
Labeler code 0409
Product ID 0409-1465_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 ANDA070916
Marketing category ANDA
Marketing start 2004-12-31
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 A070916-001 NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 20MG/ML (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 A070916-001 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 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML (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 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML (20MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP RS 1989-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML (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 A070916-001 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 A070916-001 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 A070916-001 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 A070916-001 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 A070916-001 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 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070916-001 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 A070916-001 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 A070916-001 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 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070916-001 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 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070916-001 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 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070916-001 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 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070916-001 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 A070916-001 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 A070916-001 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 A070916-001 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 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070916-001 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 A070916-001 NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 1989-02-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070916-001 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 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 · 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 0409-1465-01 Nalbuphine Hydrochloride 10 in 1 TRAY INJECTION, SOLUTION 10 34 0409-1465-71 Nalbuphine Hydrochloride 1 mL in 1 AMPULE 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 Nalbuphine Hydrochloride ACTIVE INGREDIENT ZU4275277R NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 Nalbuphine ACTIVE MOIETY L2T84IQI2K NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1465 NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 33 Current NDC, Legacy NDC, 2 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 · 1 matching rows.
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 0409-1465-01 00409146501 10 AMPULE in 1 TRAY (0409-1465-01) / 1 mL in 1 AMPULE (0409-1465-71) 10 ampule 2004-12-31 0000-00-00 No No Current