Buprenorphine

Product NDC: 58118-4459
Requested package NDC: 58118-4459-8
11-digit product format: 581184459
Labeler code: 58118
Product ID: 58118-4459_2e5a8bb5-e89c-7e3e-e063-6294a90a6b18
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buprenorphine
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Clinical Solutions Wholesale, LLC
Application: ANDA201760
Marketing category: ANDA
Marketing start: 2016-02-17
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

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
A201760-001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2016-01-29
A201760-002	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB		2016-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201760-001	AB
A201760-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201760-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201760-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2016-01-29	`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	A201760-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201760-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201760-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201760-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201760-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201760-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201760-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201760-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201760-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201760-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201760-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201760-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201760-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201760-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201760-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201760-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201760-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201760-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201760-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201760-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201760-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201760-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201760-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201760-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201760-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201760-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201760-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201760-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201760-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201760-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201760-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201760-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201760-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201760-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201760-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201760-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201760-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201760-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201760-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201760-002	AB	1	`782e0a99824c…`

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
9d976ee7-9509-49da-89fd-48d7e712697b	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58118-4459-8	Buprenorphine	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58118-4459	BUPRENORPHINE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1	Current NDC, 1 package rows	20250221_9d976ee7-9509-49da-89fd-48d7e712697b.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buprenorphine	BUPRENORPHINE	Bryant Ranch Prepack	655e3e52-03be-496c-978a-5cffc74b2ae4	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201760 application number: ANDA201760
Buprenorphine	BUPRENORPHINE	Sun Pharmaceutical Industries, Inc.	9fd1f18f-0b0f-4059-b603-19ecbf0ed63a	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201760 application number: ANDA201760
Buprenorphine	BUPRENORPHINE	AvPAK	1408cd8f-a0b5-6be7-e063-6394a90a0b41	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201760 application number: ANDA201760
Buprenorphine	BUPRENORPHINE	Redpharm Drug	3dd00186-1f1f-642a-e063-6294a90a6d20	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201760 application number: ANDA201760
Buprenorphine	BUPRENORPHINE	Clinical Solutions Wholesale, LLC	9d976ee7-9509-49da-89fd-48d7e712697b	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201760 application number: ANDA201760 ndc (package): 58118-4459-8 ndc (product): 58118-4459 ndc11 (package): 58118445908
Buprenorphine	BUPRENORPHINE	Clinical Solutions Wholesale, LLC	023c7816-21b1-4f85-be36-9e32d5935c19	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201760 application number: ANDA201760
Buprenorphine Sublingual	BUPRENORPHINE SUBLINGUAL	Direct_rx	2204e135-6a0c-68a2-e063-6394a90ac019	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201760 application number: ANDA201760

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	9d976ee7-9509-49da-89fd-48d7e712697b	1
351264	buprenorphine 2 MG Sublingual Tablet	SCD	9d976ee7-9509-49da-89fd-48d7e712697b	1
351264	buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet	SY	9d976ee7-9509-49da-89fd-48d7e712697b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58118-4459-8	58118445908	30 TABLET in 1 BLISTER PACK (58118-4459-8)	30 tablet	2025-02-17	No	No	Current