Buprenorphine

Product NDC: 0054-0177
11-digit product format: 000540177
Labeler code: 0054
Product ID: 0054-0177_e59c3c4f-a9cc-412b-b001-b9e430f537c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buprenorphine
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Hikma Pharmaceuticals USA Inc.
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: 2027-12-31
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
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
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351264	Internal RxNorm lookup
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
1bf8b35a-b769-465c-a2f8-099868dfcd2f	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
31e16ab2-c562-4617-a3e8-ed285320e16e	Product name	1	20180201
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-0177-13	Buprenorphine	30 in 1 BOTTLE	TABLET	30		32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0177-13	EA - Each	0054-0177	1bf3c40b-c21c-43e1-ac48-80d57966e698	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPRENORPHINE HYDROCHLORIDE	ACTIVE INGREDIENT	56W8MW3EN1	BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]	8
BUPRENORPHINE	ACTIVE MOIETY	40D3SCR4GZ	BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]	8
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]	8
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]	8
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]	8
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]	8
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0177	BUPRENORPHINE TABLET [HIKMA PHARMACEUTICALS USA INC.]	27	Current NDC, Legacy NDC, 1 package rows	20250514_1bf8b35a-b769-465c-a2f8-099868dfcd2f.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 ndc (product): 0054-0177
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
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
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	1bf8b35a-b769-465c-a2f8-099868dfcd2f	32
351265	buprenorphine HCl 8 MG Sublingual Tablet	PSN	1bf8b35a-b769-465c-a2f8-099868dfcd2f	32
351264	buprenorphine 2 MG Sublingual Tablet	SCD	1bf8b35a-b769-465c-a2f8-099868dfcd2f	32
351265	buprenorphine 8 MG Sublingual Tablet	SCD	1bf8b35a-b769-465c-a2f8-099868dfcd2f	32
351264	buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet	SY	1bf8b35a-b769-465c-a2f8-099868dfcd2f	32
351265	buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet	SY	1bf8b35a-b769-465c-a2f8-099868dfcd2f	32
351265	buprenorphine HCl 8 MG Sublingual Tablet	PSN	69a647c0-bc09-4ee2-aeb3-ef286caf25e5	17
351265	buprenorphine 8 MG Sublingual Tablet	SCD	69a647c0-bc09-4ee2-aeb3-ef286caf25e5	17
351265	buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet	SY	69a647c0-bc09-4ee2-aeb3-ef286caf25e5	17
351264	buprenorphine HCl 2 MG Sublingual Tablet	PSN	dba586f9-e3f2-4b9c-849b-907c81a5a0ef	9
351265	buprenorphine HCl 8 MG Sublingual Tablet	PSN	dba586f9-e3f2-4b9c-849b-907c81a5a0ef	9
351264	buprenorphine 2 MG Sublingual Tablet	SCD	dba586f9-e3f2-4b9c-849b-907c81a5a0ef	9
351265	buprenorphine 8 MG Sublingual Tablet	SCD	dba586f9-e3f2-4b9c-849b-907c81a5a0ef	9
351264	buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet	SY	dba586f9-e3f2-4b9c-849b-907c81a5a0ef	9
351265	buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet	SY	dba586f9-e3f2-4b9c-849b-907c81a5a0ef	9
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
351264	buprenorphine HCl 2 MG Sublingual Tablet	PSN	3a7418a2-bd6e-4082-b0fe-a5498e7b944a	4
351265	buprenorphine HCl 8 MG Sublingual Tablet	PSN	3a7418a2-bd6e-4082-b0fe-a5498e7b944a	4
351264	buprenorphine 2 MG Sublingual Tablet	SCD	3a7418a2-bd6e-4082-b0fe-a5498e7b944a	4
351265	buprenorphine 8 MG Sublingual Tablet	SCD	3a7418a2-bd6e-4082-b0fe-a5498e7b944a	4
351264	buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet	SY	3a7418a2-bd6e-4082-b0fe-a5498e7b944a	4
351265	buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet	SY	3a7418a2-bd6e-4082-b0fe-a5498e7b944a	4
351265	buprenorphine HCl 8 MG Sublingual Tablet	PSN	f27cb3bc-c512-fbb2-e053-2a95a90a7224	2
351265	buprenorphine 8 MG Sublingual Tablet	SCD	f27cb3bc-c512-fbb2-e053-2a95a90a7224	2
351265	buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet	SY	f27cb3bc-c512-fbb2-e053-2a95a90a7224	2
351265	buprenorphine HCl 8 MG Sublingual Tablet	PSN	248524c6-4c8b-a450-e063-6394a90a81ef	1
351265	buprenorphine 8 MG Sublingual Tablet	SCD	248524c6-4c8b-a450-e063-6394a90a81ef	1
351265	buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet	SY	248524c6-4c8b-a450-e063-6394a90a81ef	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0177-13	00054017713	30 TABLET in 1 BOTTLE (0054-0177-13)	30 tablet	2009-10-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buprenorphine	Major Pharmaceuticals	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	10
Buprenorphine HCl	REMEDYREPACK INC.	2026-03-23	HUMAN PRESCRIPTION DRUG LABEL	18
Buprenorphine	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2026-01-24	HUMAN PRESCRIPTION DRUG LABEL	32
Buprenorphine HCl	Bryant Ranch Prepack	2025-03-28	HUMAN PRESCRIPTION DRUG LABEL	7
Buprenorphine Sublingual C-III	Direct_Rx	2024-10-15	HUMAN PRESCRIPTION DRUG LABEL	1
Buprenorphine HCl	Clinical Solutions Wholesale, LLC	2024-01-08	HUMAN PRESCRIPTION DRUG LABEL	4
Buprenorphine HCl	NuCare Pharmaceuticals,Inc.	2023-01-17	HUMAN PRESCRIPTION DRUG LABEL	2
Buprenorphine HCl	Lake Erie Medical DBA Quality Care Products LLC	2019-10-15	HUMAN PRESCRIPTION DRUG LABEL	4