BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE

Product NDC: 16729-550
11-digit product format: 167290550
Labeler code: 16729
Product ID: 16729-550_799f8804-485e-46ca-b6c6-243f790f80e2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Accord Healthcare, Inc
Application: ANDA209069
Marketing category: ANDA
Marketing start: 2020-09-01
Substance: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active strength: 8; 2 mg/1; mg/1
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA], 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 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
A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2020-07-17
A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2020-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209069-001	AB
A209069-002	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 2 · 76 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	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209069-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209069-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-07-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A209069-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209069-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209069-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209069-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209069-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209069-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209069-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209069-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209069-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209069-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209069-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209069-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209069-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209069-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209069-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209069-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209069-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209069-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209069-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209069-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209069-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209069-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209069-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209069-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209069-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209069-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209069-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209069-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209069-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209069-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209069-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209069-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209069-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209069-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209069-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209069-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209069-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209069-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209069-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209069-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	8 mg/1
NALOXONE HYDROCHLORIDE DIHYDRATE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
56W8MW3EN1	Internal UNII lookup
5Q187997EE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351266	Internal RxNorm lookup
351267	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
35d29e9b-9950-452a-a795-5a7514f0edfd	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
c955d208-c333-9bd7-be34-d7e12986d44e	Product name	6	20250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304	Product name	1	20250204
caa6391e-3db3-c912-335f-61b5fc00aa12	Product name	9	20240110
08a295bb-88df-4ab0-a120-a75a789a74f1	Product name	1	20231013
65a3bc34-04ff-4cf1-aad9-c7d92a062f6d	Product name	1	20231003
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
e951cdf3-f269-4d97-a7d5-c1c3d7283a7d	Product name	3	20230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39	Product name	4	20230306
100316cc-94a9-474e-97ad-9b5c6ddec605	Product name	5	20230125
f327b80c-8fa2-404b-838a-df3eec141cf2	Product name	1	20221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119	Product name	1	20220511
539bc5d3-546b-4af6-9c31-058ce6c459d3	Product name	2	20220210
b871fccd-1de6-4c7f-b9e5-045304641ee6	Product name	8	20220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9	Product name	1	20211026
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
0b8c7273-1da3-495f-909a-7cf1e96d2361	Product name	1	20161212
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
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16729-550-10	2023-02-01	C162847	48780-1	f386c649-a1bf-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002
16729-550-10	2023-01-30	C162847	48780-1	f386c649-a1bf-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16729-550-10	BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	30 in 1 BOTTLE, PLASTIC	TABLET	30		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-550-10	EA - Each	16729-550	685afbf2-a362-4194-bc4c-4e76f2854e8b	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-550	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ACCORD HEALTHCARE, INC]	8	Current NDC, Legacy NDC, 1 package rows	20230504_35d29e9b-9950-452a-a795-5a7514f0edfd.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	Clinical Solutions Wholesale, LLC	8f2b94dc-f42f-45d5-8274-9e748ec20ef0	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209069 application number: ANDA209069
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	Redpharm Drug	44f2e26f-4586-5204-e063-6394a90a47d5	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209069 application number: ANDA209069
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	Bryant Ranch Prepack	53457b0d-3462-489e-8cf5-7cdc2ecffb48	2023-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209069 application number: ANDA209069
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	Accord Healthcare, Inc	35d29e9b-9950-452a-a795-5a7514f0edfd	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209069 application number: ANDA209069 ndc (product): 16729-550
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	Asclemed USA, Inc.	597cbc69-84b1-4255-bed9-53d0c6dc2134	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209069 application number: ANDA209069

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
56W8MW3EN1	BUPRENORPHINE HYDROCHLORIDE	53152-21-9	BUPRENORPHINE HYDROCHLORIDE
5Q187997EE	NALOXONE HYDROCHLORIDE DIHYDRATE	51481-60-8	NALOXONE HYDROCHLORIDE DIHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351267	buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet	PSN	53457b0d-3462-489e-8cf5-7cdc2ecffb48	104
351267	buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet	SCD	53457b0d-3462-489e-8cf5-7cdc2ecffb48	104
351267	buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual Tablet	SY	53457b0d-3462-489e-8cf5-7cdc2ecffb48	104
351266	buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Tablet	PSN	35d29e9b-9950-452a-a795-5a7514f0edfd	8
351267	buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet	PSN	35d29e9b-9950-452a-a795-5a7514f0edfd	8
351266	buprenorphine 2 MG / naloxone 0.5 MG Sublingual Tablet	SCD	35d29e9b-9950-452a-a795-5a7514f0edfd	8
351267	buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet	SCD	35d29e9b-9950-452a-a795-5a7514f0edfd	8
351266	buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual Tablet	SY	35d29e9b-9950-452a-a795-5a7514f0edfd	8
351267	buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual Tablet	SY	35d29e9b-9950-452a-a795-5a7514f0edfd	8
351267	buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet	PSN	44f2e26f-4586-5204-e063-6394a90a47d5	2
351267	buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet	SCD	44f2e26f-4586-5204-e063-6394a90a47d5	2
351267	buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual Tablet	SY	44f2e26f-4586-5204-e063-6394a90a47d5	2
351267	buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet	PSN	597cbc69-84b1-4255-bed9-53d0c6dc2134	1
351267	buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet	SCD	597cbc69-84b1-4255-bed9-53d0c6dc2134	1
351267	buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual Tablet	SY	597cbc69-84b1-4255-bed9-53d0c6dc2134	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-550-10	16729055010	30 TABLET in 1 BOTTLE, PLASTIC (16729-550-10)	30 tablet	2020-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Redpharm Drug	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	2
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	REMEDYREPACK INC.	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	3
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Bryant Ranch Prepack	2023-11-16	HUMAN PRESCRIPTION DRUG LABEL	104
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Accord Healthcare, Inc \| WES PHARMA INC	2023-05-03	HUMAN PRESCRIPTION DRUG LABEL	8
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-01-27	HUMAN PRESCRIPTION DRUG LABEL	1