Buprenorphine HCl and Naloxone HCl

Product NDC: 65162-416
11-digit product format: 651620416
Labeler code: 65162
Product ID: 65162-416_4cea862f-8edf-4035-a7f5-328beff51a29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buprenorphine and Naloxone
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA203136
Marketing category: ANDA
Marketing start: 2013-02-22
Substance: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active strength: 2; .5 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2013-02-22
A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2013-02-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203136-001	AB
A203136-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203136-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203136-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2013-02-22	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203136-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203136-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203136-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203136-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203136-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203136-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203136-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203136-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203136-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203136-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203136-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203136-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203136-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203136-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203136-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203136-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203136-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203136-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203136-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203136-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203136-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203136-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203136-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203136-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203136-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203136-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203136-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203136-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203136-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203136-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203136-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203136-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203136-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203136-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203136-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203136-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203136-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203136-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203136-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203136-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Buprenorphine HCl and Naloxone HCl
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	2 mg/1
NALOXONE HYDROCHLORIDE DIHYDRATE	.5 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
17b63f10-c9df-44be-80fa-6f1c305583b8	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-416-03	Buprenorphine HCl and Naloxone HCl	30 in 1 BOTTLE	TABLET	30		55
65162-416-09	Buprenorphine HCl and Naloxone HCl	90 in 1 BOTTLE	TABLET	90		55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-416-03	EA - Each	65162-416	afdba601-a5de-4c77-b2aa-3e022b1899c1	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPRENORPHINE HYDROCHLORIDE	ACTIVE INGREDIENT	56W8MW3EN1	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
NALOXONE HYDROCHLORIDE DIHYDRATE	ACTIVE INGREDIENT	5Q187997EE	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
BUPRENORPHINE	ACTIVE MOIETY	40D3SCR4GZ	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
NALOXONE	ACTIVE MOIETY	36B82AMQ7N	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]	1000
BUPRENORPHINE HYDROCHLORIDE	ACTIVE INGREDIENT	56W8MW3EN1	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
NALOXONE HYDROCHLORIDE DIHYDRATE	ACTIVE INGREDIENT	5Q187997EE	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
BUPRENORPHINE	ACTIVE MOIETY	40D3SCR4GZ	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
NALOXONE	ACTIVE MOIETY	36B82AMQ7N	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
SODIUM CITRATE, UNSPECIFIED FORM	INACTIVE INGREDIENT	1Q73Q2JULR	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	15
BUPRENORPHINE	ACTIVE INGREDIENT	40D3SCR4GZ	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5
NALOXONE	ACTIVE INGREDIENT	36B82AMQ7N	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5
BUPRENORPHINE	ACTIVE MOIETY	40D3SCR4GZ	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5
NALOXONE	ACTIVE MOIETY	36B82AMQ7N	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-416	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS LLC]	50	Current NDC, Legacy NDC, 2 package rows	20240621_17b63f10-c9df-44be-80fa-6f1c305583b8.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buprenorphine HCl and Naloxone HCl	BUPRENORPHINE AND NALOXONE	Bryant Ranch Prepack	e82e2d74-33a8-4894-82f6-788fc0f9feec	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203136 application number: ANDA203136
Buprenorphine HCl and Naloxone HCl	BUPRENORPHINE AND NALOXONE	Bryant Ranch Prepack	2aaad1a7-a0fd-4dd5-bb53-03afad8f10b9	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203136 application number: ANDA203136
Buprenorphine HCl and Naloxone HCl	BUPRENORPHINE AND NALOXONE	Amneal Pharmaceuticals LLC	17b63f10-c9df-44be-80fa-6f1c305583b8	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203136 application number: ANDA203136 ndc (product): 65162-416
Buprenorphine HCl and Naloxone HCl	BUPRENORPHINE AND NALOXONE	AvPAK	b955054b-b37d-4079-4fed-5939b763ecb4	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203136 application number: ANDA203136

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
351266	buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Tablet	PSN	2aaad1a7-a0fd-4dd5-bb53-03afad8f10b9	1007
351267	buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet	PSN	2aaad1a7-a0fd-4dd5-bb53-03afad8f10b9	1007
351266	buprenorphine 2 MG / naloxone 0.5 MG Sublingual Tablet	SCD	2aaad1a7-a0fd-4dd5-bb53-03afad8f10b9	1007
351267	buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet	SCD	2aaad1a7-a0fd-4dd5-bb53-03afad8f10b9	1007
351266	buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual Tablet	SY	2aaad1a7-a0fd-4dd5-bb53-03afad8f10b9	1007
351267	buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual Tablet	SY	2aaad1a7-a0fd-4dd5-bb53-03afad8f10b9	1007
351266	buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Tablet	PSN	17b63f10-c9df-44be-80fa-6f1c305583b8	55
351267	buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet	PSN	17b63f10-c9df-44be-80fa-6f1c305583b8	55
351266	buprenorphine 2 MG / naloxone 0.5 MG Sublingual Tablet	SCD	17b63f10-c9df-44be-80fa-6f1c305583b8	55
351267	buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet	SCD	17b63f10-c9df-44be-80fa-6f1c305583b8	55
351266	buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual Tablet	SY	17b63f10-c9df-44be-80fa-6f1c305583b8	55
351267	buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual Tablet	SY	17b63f10-c9df-44be-80fa-6f1c305583b8	55
351266	buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Tablet	PSN	b955054b-b37d-4079-4fed-5939b763ecb4	11
351267	buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet	PSN	b955054b-b37d-4079-4fed-5939b763ecb4	11
351266	buprenorphine 2 MG / naloxone 0.5 MG Sublingual Tablet	SCD	b955054b-b37d-4079-4fed-5939b763ecb4	11
351267	buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet	SCD	b955054b-b37d-4079-4fed-5939b763ecb4	11
351266	buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual Tablet	SY	b955054b-b37d-4079-4fed-5939b763ecb4	11
351267	buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual Tablet	SY	b955054b-b37d-4079-4fed-5939b763ecb4	11
351266	buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Tablet	PSN	e82e2d74-33a8-4894-82f6-788fc0f9feec	7
351266	buprenorphine 2 MG / naloxone 0.5 MG Sublingual Tablet	SCD	e82e2d74-33a8-4894-82f6-788fc0f9feec	7
351266	buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual Tablet	SY	e82e2d74-33a8-4894-82f6-788fc0f9feec	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-416-03	65162041603	30 TABLET in 1 BOTTLE (65162-416-03)	30 tablet	2013-02-22	0000-00-00	No	No	Current
65162-416-09	65162041609	90 TABLET in 1 BOTTLE (65162-416-09)	90 tablet	2013-02-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buprenorphine HCl and Naloxone HCl	Bryant Ranch Prepack	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	8
Buprenorphine HCl and Naloxone HCl	Bryant Ranch Prepack	2026-04-03	HUMAN PRESCRIPTION DRUG LABEL	1007
Buprenorphine HCl and Naloxone HCl	Amneal Pharmaceuticals LLC	2026-02-02	HUMAN PRESCRIPTION DRUG LABEL	55
Buprenorphine HCl and Naloxone HCl	AvPAK	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	11
Buprenorphine HCl and Naloxone HCl	REMEDYREPACK INC.	2024-02-14	HUMAN PRESCRIPTION DRUG LABEL	12
Buprenorphine HCl and Naloxone HCl	AvKARE, Inc.	2019-12-05	HUMAN PRESCRIPTION DRUG LABEL	12