Buprenorphine Hydrochloride

Product NDC: 21695-515
11-digit product format: 216950515
Labeler code: 21695
Product ID: 21695-515_6795ade9-e06e-4daa-bb45-821901a055f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buprenorphine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Rebel Distributors Corp
Application: ANDA074137
Marketing category: ANDA
Marketing start: 2010-07-12
Marketing end: 0000-00-00
Substance: BUPRENORPHINE HYDROCHLORIDE
Active strength: 0 mg/mL
Pharmacologic classes: Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA schedule: CIII
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-515		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-515	21695-515-10	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-515-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-515-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-515-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-515-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-515-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-515-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-515-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-515-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-515-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-515-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-515-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-515-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-515-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-515-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-515-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-515-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-515-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-515-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-515-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-515-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-515-10	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-515-10	`110d247fa046…`	`a55b01930146…`

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074137-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074137-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074137-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074137-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074137-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074137-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074137-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074137-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074137-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074137-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074137-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074137-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074137-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074137-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074137-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074137-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074137-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074137-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074137-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074137-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074137-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074137-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074137-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074137-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074137-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074137-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074137-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074137-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074137-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074137-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074137-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074137-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074137-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074137-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074137-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074137-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074137-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074137-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074137-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074137-001	AP	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
68654759-f50b-79ef-24c5-544d94fe7d87	Product name	3	20251114
08a295bb-88df-4ab0-a120-a75a789a74f1	Product name	1	20231013
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
ab841ac7-728a-4fc9-be0a-35b96cecbf39	Product name	4	20230306
100316cc-94a9-474e-97ad-9b5c6ddec605	Product name	5	20230125
539bc5d3-546b-4af6-9c31-058ce6c459d3	Product name	2	20220210
b871fccd-1de6-4c7f-b9e5-045304641ee6	Product name	8	20220118
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
31e16ab2-c562-4617-a3e8-ed285320e16e	Product name	1	20180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaef	Product name	1	20170706
a5920611-4285-f024-69b9-39ff338b81ea	Product name	5	20170609
3df867ed-9d48-45cf-bded-1394beaea0b1	Product name	3	20161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4	Product name	1	20160712
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-515-10	2019-09-24	C162847	48780-1	934fe258-48f6-48b1-e053-8cdaa90a720a	Buprenorphine Hydrochloride Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-515-10	Buprenorphine Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10		1
21695-515-10	Buprenorphine Hydrochloride	1 mL in 1 CARTRIDGE	INJECTION, SOLUTION	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-515-10	ML - Milliliter	21695-515	2c294f22-bb46-4008-bf21-af9c0cd021f4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
21695-515	BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20101220_6795ade9-e06e-4daa-bb45-821901a055f5.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Hospira, Inc.	23aa1bb3-cecf-4e62-29bb-48488bb66fc3	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074137 application number: ANDA074137

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
56W8MW3EN1	BUPRENORPHINE HYDROCHLORIDE	53152-21-9	BUPRENORPHINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1655032	buprenorphine HCl 0.3 MG in 1 ML Cartridge	PSN	6795ade9-e06e-4daa-bb45-821901a055f5	1
1655032	1 ML buprenorphine 0.3 MG/ML Cartridge	SCD	6795ade9-e06e-4daa-bb45-821901a055f5	1
1655032	buprenorphine 0.3 MG/ML (as buprenorphine HCl 0.324 MG/ML) per 1 ML Cartridge	SY	6795ade9-e06e-4daa-bb45-821901a055f5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-515-10	21695051510	10 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buprenorphine Hydrochloride Injection	Rebel Distributors Corp	2010-12-10	HUMAN PRESCRIPTION DRUG LABEL	1