BUPRENORPHINE

Product NDC: 42858-501
Requested package NDC: 42858-501-03
11-digit product format: 428580501
Labeler code: 42858
Product ID: 42858-501_5f1402cd-d222-4604-bef0-daa2b15bb4a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPRENORPHINE
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Rhodes Pharmaceuticals LLC
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: 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
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 · 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	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…`
2021-12-28 21:50 UTC	2021-12	A207276-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207276-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2017-03-27	`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	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…`
2021-12-28 21:50 UTC	2021-12	A207276-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207276-002	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	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 · 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
da90618a-5621-4b15-bc48-9dcc631418de	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
42858-501-03	BUPRENORPHINE	30 in 1 BOTTLE	TABLET	30		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42858-501-03	EA - Each	42858-501	71a92854-b20b-400b-bbab-8d3b71c8fc33	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42858-501	BUPRENORPHINE TABLET [RHODES PHARMACEUTICALS L.P.]	13	Current NDC, Legacy NDC, 1 package rows	20231229_da90618a-5621-4b15-bc48-9dcc631418de.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 ndc (package): 42858-501-03 ndc (product): 42858-501 ndc11 (package): 42858050103
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
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	cd0a90c6-32cc-4114-8573-86ac85503bdf	104
351264	buprenorphine HCl 2 MG Sublingual Tablet	PSN	bc5a7137-9e8f-438e-84d9-bdbf1db12998	104
351264	buprenorphine 2 MG Sublingual Tablet	SCD	cd0a90c6-32cc-4114-8573-86ac85503bdf	104
351264	buprenorphine 2 MG Sublingual Tablet	SCD	bc5a7137-9e8f-438e-84d9-bdbf1db12998	104
351264	buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet	SY	cd0a90c6-32cc-4114-8573-86ac85503bdf	104
351264	buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet	SY	bc5a7137-9e8f-438e-84d9-bdbf1db12998	104
351264	buprenorphine HCl 2 MG Sublingual Tablet	PSN	da90618a-5621-4b15-bc48-9dcc631418de	16
351265	buprenorphine HCl 8 MG Sublingual Tablet	PSN	da90618a-5621-4b15-bc48-9dcc631418de	16
351264	buprenorphine 2 MG Sublingual Tablet	SCD	da90618a-5621-4b15-bc48-9dcc631418de	16
351265	buprenorphine 8 MG Sublingual Tablet	SCD	da90618a-5621-4b15-bc48-9dcc631418de	16
351264	buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet	SY	da90618a-5621-4b15-bc48-9dcc631418de	16
351265	buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet	SY	da90618a-5621-4b15-bc48-9dcc631418de	16
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
351264	buprenorphine HCl 2 MG Sublingual Tablet	PSN	8d38f7aa-da0b-40ad-b0d1-4284c71042ed	5
351265	buprenorphine HCl 8 MG Sublingual Tablet	PSN	8d38f7aa-da0b-40ad-b0d1-4284c71042ed	5
351264	buprenorphine 2 MG Sublingual Tablet	SCD	8d38f7aa-da0b-40ad-b0d1-4284c71042ed	5
351265	buprenorphine 8 MG Sublingual Tablet	SCD	8d38f7aa-da0b-40ad-b0d1-4284c71042ed	5
351264	buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet	SY	8d38f7aa-da0b-40ad-b0d1-4284c71042ed	5
351265	buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet	SY	8d38f7aa-da0b-40ad-b0d1-4284c71042ed	5
351264	buprenorphine HCl 2 MG Sublingual Tablet	PSN	325532f0-276f-4689-97d6-cda879b4c758	2
351264	buprenorphine 2 MG Sublingual Tablet	SCD	325532f0-276f-4689-97d6-cda879b4c758	2
351264	buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet	SY	325532f0-276f-4689-97d6-cda879b4c758	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42858-501-03	42858050103	30 TABLET in 1 BOTTLE (42858-501-03)	30 tablet	2017-10-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUPRENORPHINE	Unit Dose Solutions, Inc.	2026-06-17	HUMAN PRESCRIPTION DRUG LABEL	1
BUPRENORPHINE	Bryant Ranch Prepack	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL	105
BUPRENORPHINE	Rhodes Pharmaceuticals LLC \| Knoa Pharmaceuticals LLC	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	16
BUPRENORPHINE	Bryant Ranch Prepack	2026-04-03	HUMAN PRESCRIPTION DRUG LABEL	104
BUPRENORPHINE	Bryant Ranch Prepack	2025-07-29	HUMAN PRESCRIPTION DRUG LABEL	7
Buprenorphine	American Health Packaging	2024-12-30	HUMAN PRESCRIPTION DRUG LABEL	5
BUPRENORPHINE	Correct Rx Pharmacy Services, Inc. \| Unit Dose Solutions, Inc.	2024-01-23	HUMAN PRESCRIPTION DRUG LABEL	1
BUPRENORPHINE	Clinical Solutions Wholesale, LLC	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	2
BUPRENORPHINE	Correct Rx Pharmacy Services, Inc.	2023-12-12	HUMAN PRESCRIPTION DRUG LABEL	1
BUPRENORPHINE	REMEDYREPACK INC.	2023-08-22	HUMAN PRESCRIPTION DRUG LABEL	5