Buprenorphine and Naloxone

Product NDC: 0378-8767
11-digit product format: 003788767
Labeler code: 0378
Product ID: 0378-8767_008d89ec-5bd7-46d9-bc94-9cdc7405f95d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buprenorphine and Naloxone
Dosage form: FILM
Route: BUCCAL; SUBLINGUAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA207607
Marketing category: ANDA
Marketing start: 2019-02-20
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: 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
A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB		2018-06-14
A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB		2018-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207607-001	AB
A207607-002	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	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207607-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207607-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`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	A207607-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207607-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207607-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207607-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207607-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207607-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207607-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207607-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207607-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207607-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207607-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207607-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207607-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207607-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207607-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207607-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207607-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207607-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207607-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207607-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207607-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207607-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207607-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207607-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207607-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207607-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207607-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207607-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207607-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207607-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207607-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207607-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207607-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207607-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207607-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207607-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207607-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207607-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207607-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207607-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

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
5Q187997EE	Internal UNII lookup
56W8MW3EN1	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1010600	Internal RxNorm lookup
1010604	Internal RxNorm lookup
1307056	Internal RxNorm lookup
1307061	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
557d8d4d-8751-431c-b18e-9d5cf23fc579	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-8767-16	Buprenorphine and Naloxone	1 in 1 POUCH	FILM	1		12
0378-8767-93	Buprenorphine and Naloxone	30 in 1 CARTON	FILM	30		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-8767-16	EA - Each	0378-8767	3b525181-1585-4454-b614-de6fc7a5701d	1	2019-03-12
0378-8767-93	EA - Each	0378-8767	4d18bc88-54d2-400f-9b9f-af209f2b64fd	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-8767	BUPRENORPHINE AND NALOXONE FILM [MYLAN PHARMACEUTICALS INC.]	8	Current NDC, Legacy NDC, 2 package rows	20240418_557d8d4d-8751-431c-b18e-9d5cf23fc579.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Mylan Pharmaceuticals Inc.	557d8d4d-8751-431c-b18e-9d5cf23fc579	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207607 application number: ANDA207607 ndc (product): 0378-8767

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
1307061	buprenorphine HCl 12 MG / naloxone HCl 3 MG Sublingual Film	PSN	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1010600	buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Film	PSN	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1307056	buprenorphine HCl 4 MG / naloxone HCl 1 MG Sublingual Film	PSN	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1010604	buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Film	PSN	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1307061	buprenorphine 12 MG / naloxone 3 MG Sublingual Film	SCD	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1010600	buprenorphine 2 MG / naloxone 0.5 MG Sublingual Film	SCD	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1307056	buprenorphine 4 MG / naloxone 1 MG Sublingual Film	SCD	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1010604	buprenorphine 8 MG / naloxone 2 MG Sublingual Film	SCD	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1307061	buprenorphine 12 MG / naloxone 3 MG Sublingual Film	SY	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1010600	buprenorphine 2 MG / naloxone 0.5 MG Buccal Film	SY	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1010600	buprenorphine 2 MG / naloxone 0.5 MG Sublingual Film	SY	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1307056	buprenorphine 4 MG / naloxone 1 MG Buccal Film	SY	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1307056	buprenorphine 4 MG / naloxone 1 MG Sublingual Film	SY	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1010604	buprenorphine 8 MG / naloxone 2 MG Buccal Film	SY	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1010604	buprenorphine 8 MG / naloxone 2 MG Sublingual Film	SY	557d8d4d-8751-431c-b18e-9d5cf23fc579	12
1010604	buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Film	PSN	11700342-b4a7-3758-e063-6294a90af6ac	2
1010604	buprenorphine 8 MG / naloxone 2 MG Sublingual Film	SCD	11700342-b4a7-3758-e063-6294a90af6ac	2
1010604	buprenorphine 8 MG / naloxone 2 MG Buccal Film	SY	11700342-b4a7-3758-e063-6294a90af6ac	2
1010604	buprenorphine 8 MG / naloxone 2 MG Sublingual Film	SY	11700342-b4a7-3758-e063-6294a90af6ac	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-8767-16	00378876716	1 in 1 POUCH						Historical
0378-8767-93	00378876793	30 POUCH in 1 CARTON (0378-8767-93) / 1 FILM in 1 POUCH (0378-8767-16)	30 pouch	2019-02-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buprenorphine and Naloxone - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2026-01-15	HUMAN PRESCRIPTION DRUG LABEL	12
Buprenorphine and Naloxone - Redpharm drug	Redpharm drug	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	2
Buprenorphine and Naloxone - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2019-11-07	HUMAN PRESCRIPTION DRUG LABEL	5