BACLOFEN

Product NDC: 61919-095
11-digit product format: 619190095
Labeler code: 61919
Product ID: 61919-095_b6739402-fd84-79d1-e053-2a95a90acc02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BACLOFEN
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA077241
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: BACLOFEN
Active strength: 20 mg/1
Pharmacologic classes: GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-095		I	Inactivated by FDA	2026-08-10
excluded product	product	61919-095		I	Inactivated by FDA	2026-08-10
excluded package	package	61919-095	61919-095-60	I	Inactivated by FDA	2026-08-10
excluded package	package	61919-095	61919-095-82	I	Inactivated by FDA	2026-08-10
excluded package	package	61919-095	61919-095-90	I	Inactivated by FDA	2026-08-10
excluded package	package	61919-095	61919-095-30	I	Inactivated by FDA	2026-08-10
excluded package	package	61919-095	61919-095-86	I	Inactivated by FDA	2026-08-10

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 2 · 72 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-095-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-095-82	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-095-86	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-095-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-095-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-095-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-095-82	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-095-86	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-095-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-095-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-095-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-095-82	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-095-86	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-095-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-095-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-095-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-095-82	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-095-86	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-095-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-095-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-095-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-095-82	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-095-86	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-095-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-095-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-095-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-095-82	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-095-86	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-095-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-095-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-095-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-095-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-095-82	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-095-90	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-095-86	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-095-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-095-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-095-82	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-095-90	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-095-86	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-095-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-095-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077241-001	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20
A077241-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06
A077241-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077241-001	AB
A077241-002	AB
A077241-003	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 · 115 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	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 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	A077241-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077241-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077241-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077241-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077241-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077241-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077241-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077241-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077241-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077241-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077241-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077241-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077241-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346	Product name	2	20251208
1b1393e5-f2d8-42f5-a070-e3416d619667	Product name	1	20250804
88583480-702d-4dfe-a31c-9c00abd818f8	Product name	7	20250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83d	Product name	2	20240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9d	Product name	1	20220613
ef6bc0bf-8134-f06b-70d9-4980df6f808e	Product name	5	20210615
eeec0918-7a2f-44bf-83d6-1216e507adbf	Product name	3	20191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75	Product name	1	20190611

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-095-30	2025-01-30	2cef2736-afd7-d83d-e063-dadaa90ab31f	BACLOFEN
61919-095-60	2025-01-30	9d75b9d0-40c6-f424-e053-dadaa90a57ce	BACLOFEN
61919-095-82	2025-01-30	9d75b9d0-40c6-f424-e053-dadaa90a57ce	BACLOFEN
61919-095-86	2025-01-30	2cef2736-afd7-d83d-e063-dadaa90ab31f	BACLOFEN
61919-095-90	2025-01-30	9d75b9d0-40c6-f424-e053-dadaa90a57ce	BACLOFEN
61919-095-60	2020-12-14	9d75b9d0-40c6-f424-e053-dadaa90a57ce	BACLOFEN
61919-095-90	2020-12-14	9d75b9d0-40c6-f424-e053-dadaa90a57ce	BACLOFEN
61919-095-60	2020-01-31	9d75b9d0-40c6-f424-e053-dadaa90a57ce	BACLOFEN
61919-095-90	2020-01-31	9d75b9d0-40c6-f424-e053-dadaa90a57ce	BACLOFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-095-60	BACLOFEN	60 in 1 BOTTLE	TABLET	60	6
61919-095-82	BACLOFEN	180 in 1 BOTTLE	TABLET	180	6
61919-095-90	BACLOFEN	90 in 1 BOTTLE	TABLET	90	6
61919-095-30	BACLOFEN	30 in 1 BOTTLE	TABLET	30	3
61919-095-86	BACLOFEN	270 in 1 BOTTLE	TABLET	270	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-095-30	EA - Each	61919-095	ee9ef1da-9347-44f9-ae3b-9c4dc5f165a6	1	2019-08-06
61919-095-60	EA - Each	61919-095	968d84a8-e787-45eb-bc88-c4ce446af965	1	2015-02-02
61919-095-82	EA - Each	61919-095	802434d2-88fb-47fb-9fd8-9eeabcd61638	1	2024-01-04
61919-095-86	EA - Each	61919-095	a7725d34-2fbe-4d29-8b55-c2031fd603b0	1	2019-11-12
61919-095-90	EA - Each	61919-095	2316f0d9-e3bc-4154-bd7e-fcb3a6dd5a54	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [DIRECT RX]	2
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [DIRECT RX]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [DIRECT RX]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-095	BACLOFEN TABLET [DIRECT RX]	6	Legacy NDC, 3 package rows	20231205_7d164f22-a8d8-4ad1-9ea2-f29cc73b7ec8.zip
61919-095	BACLOFEN TABLET [DIRECT_RX]	3	Legacy NDC, 2 package rows	20200118_8ed82315-6003-8308-e053-2995a90a0d4d.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Cardinal Health 107, LLC	2278954a-7605-426a-ae85-1bf0a3117420	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Major Pharmaceuticals	ae732bdc-5178-4565-8219-d1787a5211a6	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	cfcf519f-5d15-431d-89c8-961a0c38ba60	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Marlex Pharmaceuticals Inc	1b0f50c8-62e3-414d-96d3-5fd16e8043ab	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	b4f2f888-979a-6f54-e053-2a95a90a95a3	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Chartwell RX, LLC	2a75db96-590a-43cf-aefb-3bbcb287dbf0	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Bryant Ranch Prepack	7f27f935-b1fa-4494-9014-7f62c59bb8e3	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Bryant Ranch Prepack	b4506087-be24-4e76-9fb8-b07805137072	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	c582972d-22ef-4326-b37f-adf2ca0b1875	2023-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Bryant Ranch Prepack	58816b46-28a5-48e2-b89d-98df65939386	2023-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Bryant Ranch Prepack	9110b1cb-8604-4824-9337-84b08d41dd3c	2023-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Lannett Company, Inc.	f84f3f4c-17e6-43f1-9600-63b0b175837b	2021-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Proficient Rx LP	924a01fb-0ed0-4f73-9304-d6c5b9961d66	2020-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H789N3FKE8	BACLOFEN	1134-47-0	BACLOFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197392	baclofen 20 MG Oral Tablet	PSN	7d164f22-a8d8-4ad1-9ea2-f29cc73b7ec8	6
197392	baclofen 20 MG Oral Tablet	SCD	7d164f22-a8d8-4ad1-9ea2-f29cc73b7ec8	6
197392	baclofen 20 MG Oral Tablet	PSN	8ed82315-6003-8308-e053-2995a90a0d4d	3
197392	baclofen 20 MG Oral Tablet	SCD	8ed82315-6003-8308-e053-2995a90a0d4d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-095-30	61919009530	30 TABLET in 1 BOTTLE (61919-095-30)	30 tablet	2019-07-29	0000-00-00	No	No	Current
61919-095-60	61919009560	60 TABLET in 1 BOTTLE (61919-095-60)	60 tablet	2015-04-29	0000-00-00	No	No	Current
61919-095-82	61919009582	180 in 1 BOTTLE						Historical
61919-095-86	61919009586	270 TABLET in 1 BOTTLE (61919-095-86)	270 tablet	2019-07-29	0000-00-00	No	No	Current
61919-095-90	61919009590	90 TABLET in 1 BOTTLE (61919-095-90)	90 tablet	2015-04-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN	DIRECT RX	2023-12-04	HUMAN PRESCRIPTION DRUG LABEL	6
BACLOFEN	Direct_Rx	2020-01-17	HUMAN PRESCRIPTION DRUG LABEL	3