Buprenorphine and Naloxone

Product NDC: 53217-138
11-digit product format: 532170138
Labeler code: 53217
Product ID: 53217-138_7511903e-4f5d-4fc3-8d82-08eca9a9c67b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buprenorphine hydrochloride and naloxone hydrochloride
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA204431
Marketing category: ANDA
Marketing start: 2015-12-10
Marketing end: 0000-00-00
Substance: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active strength: 8 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: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53217-138		I	Inactivated by FDA		2026-09-14
excluded package	package	53217-138	53217-138-30	I	Inactivated by FDA		2026-09-14

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-138-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-138-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-138-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-138-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-138-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-138-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-138-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-138-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-138-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-138-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53217-138-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53217-138-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53217-138-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53217-138-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53217-138-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53217-138-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53217-138-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53217-138-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53217-138-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53217-138-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53217-138-30	`9bebd1f3094a…`	`5416666fcb17…`

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
A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2015-10-16
A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2015-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204431-001	AB
A204431-002	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	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204431-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204431-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-10-16	`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	A204431-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204431-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204431-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204431-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204431-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204431-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204431-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204431-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204431-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204431-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204431-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204431-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204431-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204431-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204431-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204431-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204431-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204431-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204431-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204431-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204431-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204431-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204431-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204431-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204431-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204431-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204431-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204431-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204431-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204431-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204431-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204431-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204431-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204431-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204431-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204431-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204431-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204431-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204431-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204431-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

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
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
31e16ab2-c562-4617-a3e8-ed285320e16e	Product name	1	20180201
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
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-138-30	2020-01-31	C162847	48780-1	9d75b9d0-f50b-f424-e053-dadaa90a57ce	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
53217-138-30	Buprenorphine and Naloxone	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-138-30	EA - Each	53217-138	bff4dfab-89d4-42e0-93f4-24cf6b9146d7	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-138	BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20161206_fb7e9780-2576-4a0d-afa0-d0ce0c1dcad2.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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	d5b011ef-f1be-47f2-8f8b-07553f36193c	2026-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204431 application number: ANDA204431

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
56W8MW3EN1	BUPRENORPHINE HYDROCHLORIDE	53152-21-9	BUPRENORPHINE HYDROCHLORIDE
F850569PQR	NALOXONE HYDROCHLORIDE	357-08-4	NALOXONE HYDROCHLORIDE

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	fb7e9780-2576-4a0d-afa0-d0ce0c1dcad2	1
351267	buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet	SCD	fb7e9780-2576-4a0d-afa0-d0ce0c1dcad2	1
351267	buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual Tablet	SY	fb7e9780-2576-4a0d-afa0-d0ce0c1dcad2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-138-30	53217013830	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buprenorphine and Naloxone	Aidarex Pharmaceuticals LLC	2016-12-06	HUMAN PRESCRIPTION DRUG LABEL	1