Buprenorphine HCl and Naloxone HCl

Product NDC: 0406-1923
Requested package NDC: 0406-1923-03
11-digit product format: 004061923
Labeler code: 0406
Product ID: 0406-1923_48d02539-47bb-4b3c-91ea-453039c6da7a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buprenorphine and Naloxone
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: SpecGx LLC
Application: ANDA203136
Marketing category: ANDA
Marketing start: 2013-02-22
Marketing end: 2021-02-28
Substance: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active strength: 2 mg/1; mg/1
Pharmacologic classes: Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0406-1923	0406-1923-03	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-1923-03	EA - Each	0406-1923	a867309c-8f61-4375-8e94-f3ff308391ab	1	2013-11-04

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 [MALLINCKRODT, INC.]	3
NALOXONE HYDROCHLORIDE DIHYDRATE	ACTIVE INGREDIENT	5Q187997EE	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]	3
BUPRENORPHINE	ACTIVE MOIETY	40D3SCR4GZ	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]	3
NALOXONE	ACTIVE MOIETY	36B82AMQ7N	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]	3

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0406-1923-03	00406192303	30 TABLET in 1 BOTTLE (0406-1923-03)	30 tablet	2013-02-22	2021-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buprenorphine HCl and Naloxone HCl	SpecGx LLC \| Amneal Pharmaceuticals of New York, LLC	2019-04-30	HUMAN PRESCRIPTION DRUG LABEL	14