Buprenorphine HCl

Product NDC: 71335-1163
Requested package NDC: 71335-1163-0
11-digit product format: 713351163
Labeler code: 71335
Product ID: 71335-1163_4ee49cc8-55ca-4274-9ea6-70d7891d8853
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buprenorphine HCl
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Bryant Ranch Prepack
Application: ANDA078633
Marketing category: ANDA
Marketing start: 2009-10-08
Substance: BUPRENORPHINE HYDROCHLORIDE
Active strength: 8 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1163	71335-1163-0	I	Inactivated by FDA		excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1163	71335-1163-0	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078633-001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08
A078633-002	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078633-001	AB
A078633-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078633-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078633-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078633-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078633-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078633-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078633-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078633-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078633-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078633-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078633-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078633-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078633-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078633-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078633-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078633-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078633-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078633-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078633-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078633-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078633-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078633-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078633-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078633-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078633-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078633-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078633-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078633-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078633-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078633-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078633-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078633-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078633-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078633-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078633-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078633-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078633-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078633-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078633-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078633-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078633-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	8 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
351265	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
d5a8c41e-413e-4d48-9739-d158e5681dd0	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
71335-1163-0	2024-05-20	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-1	2024-05-20	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-2	2024-05-20	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-3	2024-05-20	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-4	2024-05-20	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-5	2024-05-20	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-6	2024-05-20	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-7	2024-05-20	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-8	2024-05-20	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-9	2024-05-20	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-0	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-1	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-2	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-3	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-4	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-5	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-6	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-7	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-8	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, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-9	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, for sublingual administration CIII Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1163-0	Buprenorphine HCl	120 in 1 BOTTLE	TABLET	120	7
71335-1163-1	Buprenorphine HCl	90 in 1 BOTTLE	TABLET	90	7
71335-1163-2	Buprenorphine HCl	60 in 1 BOTTLE	TABLET	60	7
71335-1163-3	Buprenorphine HCl	30 in 1 BOTTLE	TABLET	30	7
71335-1163-4	Buprenorphine HCl	20 in 1 BOTTLE	TABLET	20	7
71335-1163-5	Buprenorphine HCl	7 in 1 BOTTLE	TABLET	7	7
71335-1163-6	Buprenorphine HCl	28 in 1 BOTTLE	TABLET	28	7
71335-1163-7	Buprenorphine HCl	1 in 1 BOTTLE	TABLET	1	7
71335-1163-8	Buprenorphine HCl	12 in 1 BOTTLE	TABLET	12	7
71335-1163-9	Buprenorphine HCl	14 in 1 BOTTLE	TABLET	14	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1163-1	EA - Each	71335-1163	8541cd7b-30c3-4502-bb02-5b7544b8fe08	1	2021-04-08
71335-1163-2	EA - Each	71335-1163	d2607102-2a9c-4034-b169-098b624c55f3	1	2021-04-08
71335-1163-3	EA - Each	71335-1163	e89c974d-a9f4-44e6-aa80-92df7d6c6a95	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1163	BUPRENORPHINE HCL TABLET [BRYANT RANCH PREPACK]	7	Current NDC, Legacy NDC, 10 package rows	20250331_d5a8c41e-413e-4d48-9739-d158e5681dd0.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buprenorphine HCl	BUPRENORPHINE HCL	REMEDYREPACK INC.	e1aac2bb-cb83-46cb-9a29-502a62010667	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633
Buprenorphine	BUPRENORPHINE	Major Pharmaceuticals	dba586f9-e3f2-4b9c-849b-907c81a5a0ef	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633
Buprenorphine HCl	BUPRENORPHINE HCL	REMEDYREPACK INC.	69a647c0-bc09-4ee2-aeb3-ef286caf25e5	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633
Buprenorphine	BUPRENORPHINE	Hikma Pharmaceuticals USA Inc.	1bf8b35a-b769-465c-a2f8-099868dfcd2f	2026-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633
Buprenorphine HCl	BUPRENORPHINE HCL	Redpharm Drug	301eaed5-8499-ad95-e063-6294a90a58f5	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633
Buprenorphine HCl	BUPRENORPHINE HCL	Bryant Ranch Prepack	d5a8c41e-413e-4d48-9739-d158e5681dd0	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633 ndc (package): 71335-1163-0 ndc (product): 71335-1163 ndc11 (package): 71335116300
Buprenorphine Sublingual C-III	BUPRENORPHINE SUBLINGUAL C-III	Direct_Rx	22412030-a641-28d8-e063-6294a90a2fef	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633
Buprenorphine Sublingual C-III	BUPRENORPHINE SUBLINGUAL C-III	Direct_Rx	248524c6-4c8b-a450-e063-6394a90a81ef	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633
Buprenorphine HCl	BUPRENORPHINE HCL	Clinical Solutions Wholesale, LLC	3a7418a2-bd6e-4082-b0fe-a5498e7b944a	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633

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
351265	buprenorphine HCl 8 MG Sublingual Tablet	PSN	d5a8c41e-413e-4d48-9739-d158e5681dd0	7
351265	buprenorphine 8 MG Sublingual Tablet	SCD	d5a8c41e-413e-4d48-9739-d158e5681dd0	7
351265	buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet	SY	d5a8c41e-413e-4d48-9739-d158e5681dd0	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1163-0	71335116300	120 TABLET in 1 BOTTLE (71335-1163-0)	120 tablet	2024-05-17	0000-00-00	No	No	Current