BUPRENORPHINE

Product NDC: 71335-0950
11-digit product format: 713350950
Labeler code: 71335
Product ID: 71335-0950_942860b1-ae08-462f-927a-d611ad05dc40
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPRENORPHINE
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Bryant Ranch Prepack
Application: ANDA207276
Marketing category: ANDA
Marketing start: 2017-10-25
Substance: BUPRENORPHINE HYDROCHLORIDE
Active strength: 2 mg/1
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

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 · 18 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
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	71335-0950-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0950-7	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0950-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0950-5	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0950-8	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0950-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0950-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0950-6	`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	71335-0950-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0950-7	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0950-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0950-5	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0950-8	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0950-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0950-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0950-6	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207276-001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2017-03-27
A207276-002	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB		2017-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207276-001	AB
A207276-002	AB

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 3 · 84 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	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A207276-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207276-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207276-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207276-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207276-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207276-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207276-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207276-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207276-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207276-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207276-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207276-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207276-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207276-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207276-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207276-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207276-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207276-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207276-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207276-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207276-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207276-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207276-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207276-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207276-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207276-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207276-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207276-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207276-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207276-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207276-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207276-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207276-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207276-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207276-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207276-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207276-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207276-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207276-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207276-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: BUPRENORPHINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	2 mg/1

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
351264	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a7da638f-f590-4577-bff9-15a91c6e7917	Available on FDA.report

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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71335-0950-1	2024-05-15	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-2	2024-05-15	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-3	2024-05-15	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-4	2024-05-15	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-5	2024-05-15	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-6	2024-05-15	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-7	2024-05-15	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-8	2024-05-15	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-1	2024-01-30	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-2	2024-01-30	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-3	2024-01-30	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-4	2024-01-30	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-5	2024-01-30	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-6	2024-01-30	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-7	2024-01-30	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981
71335-0950-8	2024-01-30	These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0950-1	BUPRENORPHINE	60 in 1 BOTTLE	TABLET	60	7
71335-0950-2	BUPRENORPHINE	90 in 1 BOTTLE	TABLET	90	7
71335-0950-3	BUPRENORPHINE	30 in 1 BOTTLE	TABLET	30	7
71335-0950-4	BUPRENORPHINE	7 in 1 BOTTLE	TABLET	7	7
71335-0950-5	BUPRENORPHINE	28 in 1 BOTTLE	TABLET	28	7
71335-0950-6	BUPRENORPHINE	1 in 1 BOTTLE	TABLET	1	7
71335-0950-7	BUPRENORPHINE	12 in 1 BOTTLE	TABLET	12	7
71335-0950-8	BUPRENORPHINE	120 in 1 BOTTLE	TABLET	120	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0950-1	EA - Each	71335-0950	575bbc6c-1bc3-45d5-ac8f-bb725b2768a0	1	2021-04-08
71335-0950-2	EA - Each	71335-0950	8cd1988c-1010-4e2c-9434-049d91e0f681	1	2021-04-08
71335-0950-3	EA - Each	71335-0950	0a780a1c-205a-4211-a34a-a101462f6c22	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0950	BUPRENORPHINE TABLET [BRYANT RANCH PREPACK]	6	Current NDC, Legacy NDC, 8 package rows	20240517_a7da638f-f590-4577-bff9-15a91c6e7917.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPRENORPHINE	BUPRENORPHINE	Unit Dose Solutions, Inc.	5578cd5c-c860-6e8a-e063-6394a90a56c7	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207276 application number: ANDA207276
BUPRENORPHINE	BUPRENORPHINE	Bryant Ranch Prepack	aa132031-9d12-45b4-81e0-4a5877661379	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207276 application number: ANDA207276
BUPRENORPHINE	BUPRENORPHINE	Unit Dose Solutions, Inc.	5479b218-a388-2c3c-e063-6294a90a0e85	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207276 application number: ANDA207276
BUPRENORPHINE	BUPRENORPHINE	Bryant Ranch Prepack	966adb01-71b4-4e0b-bbc6-b83da9987aa2	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207276 application number: ANDA207276
BUPRENORPHINE	BUPRENORPHINE	Bryant Ranch Prepack	bc5a7137-9e8f-438e-84d9-bdbf1db12998	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207276 application number: ANDA207276
BUPRENORPHINE	BUPRENORPHINE	Rhodes Pharmaceuticals LLC	da90618a-5621-4b15-bc48-9dcc631418de	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207276 application number: ANDA207276
BUPRENORPHINE	BUPRENORPHINE	Bryant Ranch Prepack	cd0a90c6-32cc-4114-8573-86ac85503bdf	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207276 application number: ANDA207276
BUPRENORPHINE	BUPRENORPHINE	A-S Medication Solutions	bfb02ea5-22f2-432e-afc8-f1dbe2ea0614	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207276 application number: ANDA207276
BUPRENORPHINE	BUPRENORPHINE	Bryant Ranch Prepack	a7da638f-f590-4577-bff9-15a91c6e7917	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207276 application number: ANDA207276 ndc (product): 71335-0950
Buprenorphine	BUPRENORPHINE	American Health Packaging	8d38f7aa-da0b-40ad-b0d1-4284c71042ed	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207276 application number: ANDA207276
BUPRENORPHINE	BUPRENORPHINE	Clinical Solutions Wholesale, LLC	2181e700-caa1-48c4-90ce-60fec053ba6a	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207276 application number: ANDA207276
BUPRENORPHINE	BUPRENORPHINE	Clinical Solutions Wholesale, LLC	325532f0-276f-4689-97d6-cda879b4c758	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207276 application number: ANDA207276

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
56W8MW3EN1	BUPRENORPHINE HYDROCHLORIDE	53152-21-9	BUPRENORPHINE HYDROCHLORIDE
40D3SCR4GZ	BUPRENORPHINE	52485-79-7	BUPRENORPHINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351264	buprenorphine HCl 2 MG Sublingual Tablet	PSN	a7da638f-f590-4577-bff9-15a91c6e7917	7
351264	buprenorphine 2 MG Sublingual Tablet	SCD	a7da638f-f590-4577-bff9-15a91c6e7917	7
351264	buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet	SY	a7da638f-f590-4577-bff9-15a91c6e7917	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0950-1	71335095001	60 TABLET in 1 BOTTLE (71335-0950-1)	60 tablet	2018-09-13	0000-00-00	No	No	Current
71335-0950-2	71335095002	90 TABLET in 1 BOTTLE (71335-0950-2)	90 tablet	2018-09-13	0000-00-00	No	No	Current
71335-0950-3	71335095003	30 TABLET in 1 BOTTLE (71335-0950-3)	30 tablet	2022-09-23	0000-00-00	No	No	Current
71335-0950-4	71335095004	7 TABLET in 1 BOTTLE (71335-0950-4)	7 tablet	2022-09-23	0000-00-00	No	No	Current
71335-0950-5	71335095005	28 TABLET in 1 BOTTLE (71335-0950-5)	28 tablet	2022-09-23	0000-00-00	No	No	Current
71335-0950-6	71335095006	1 TABLET in 1 BOTTLE (71335-0950-6)	1 tablet	2022-09-23	0000-00-00	No	No	Current
71335-0950-7	71335095007	12 TABLET in 1 BOTTLE (71335-0950-7)	12 tablet	2022-09-23	0000-00-00	No	No	Current
71335-0950-8	71335095008	120 TABLET in 1 BOTTLE (71335-0950-8)	120 tablet	2022-09-23	0000-00-00	No	No	Current