Home NDC 0409-2012 Buprenorphine Hydrochloride
Product NDC 0409-2012
11-digit product format 004092012
Labeler code 0409
Product ID 0409-2012_37d2deb6-c54a-42bb-ad76-4873a59da562
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Buprenorphine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA074137
Marketing category ANDA
Marketing start 2005-06-14
Substance BUPRENORPHINE HYDROCHLORIDE
Active strength .3 mg/mL
Pharmacologic classes Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule CIII
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 42 .
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 A074137-001 BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074137-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074137-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 1996-06-03 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Buprenorphine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPRENORPHINE HYDROCHLORIDE .3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 56W8MW3EN1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1655032 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 0409-2012-03 Buprenorphine Hydrochloride 1 mL in 1 CARTRIDGE INJECTION, SOLUTION 1 20 0409-2012-32 Buprenorphine Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUPRENORPHINE HYDROCHLORIDE ACTIVE INGREDIENT 56W8MW3EN1 BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10 Buprenorphine ACTIVE MOIETY 40D3SCR4GZ BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10 ANHYDROUS DEXTROSE INACTIVE INGREDIENT 5SL0G7R0OK BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10 WATER INACTIVE INGREDIENT 059QF0KO0R BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10 BUPRENORPHINE HYDROCHLORIDE ACTIVE INGREDIENT 56W8MW3EN1 BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 Buprenorphine ACTIVE MOIETY 40D3SCR4GZ BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS DEXTROSE INACTIVE INGREDIENT 5SL0G7R0OK BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-2012 BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 19 Current NDC, Legacy NDC, 2 package rows 20240726_23aa1bb3-cecf-4e62-29bb-48488bb66fc3.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 0409-2012-03 00409201203 1 mL in 1 CARTRIDGE 1 ml Historical 0409-2012-32 00409201232 10 CARTRIDGE in 1 CARTON (0409-2012-32) / 1 mL in 1 CARTRIDGE (0409-2012-03) 10 cartridge 2005-06-14 0000-00-00 No No Current