Baclofen

Product NDC: 53808-0889
11-digit product format: 538080889
Labeler code: 53808
Product ID: 53808-0889_425b8fc9-64d0-435f-9e42-1fc2d19b5be3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA077068
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: 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	53808-0889		I	Inactivated by FDA		2026-08-03
excluded package	package	53808-0889	53808-0889-1	I	Inactivated by FDA		2026-08-03

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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`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	53808-0889-1	`9bebd1f3094a…`	`5416666fcb17…`

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
A077068-001	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB		2005-08-30
A077068-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB		2005-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077068-001	AB
A077068-002	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	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`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	A077068-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077068-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077068-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077068-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077068-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077068-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077068-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077068-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077068-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077068-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077068-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077068-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077068-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077068-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077068-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077068-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077068-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077068-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077068-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077068-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077068-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077068-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077068-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077068-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077068-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077068-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077068-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077068-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077068-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077068-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077068-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077068-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077068-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077068-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077068-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077068-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077068-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077068-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077068-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077068-002	AB	1	`782e0a99824c…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0889-1	2020-01-31	C162847	48780-1	9d75b9d0-91ff-f424-e053-dadaa90a57ce	BACLOFEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0889-1	Baclofen	30 in 1 BLISTER PACK	TABLET	30		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0889	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2	Legacy NDC, 1 package rows	20141014_0308ca55-2461-4500-8e35-1d26282d3679.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Bryant Ranch Prepack	7b6d33d8-58c2-448d-a8df-1de7339b1520	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077068 application number: ANDA077068
Baclofen	BACLOFEN	Bryant Ranch Prepack	4cbb2264-ef65-4906-86e5-349deeeda7a9	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077068 application number: ANDA077068
Baclofen	BACLOFEN	Bryant Ranch Prepack	32525b4e-6384-49e1-a66d-abe45484ab86	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077068 application number: ANDA077068
Baclofen	BACLOFEN	Bryant Ranch Prepack	e13c0563-0f32-4199-acb0-ad2376ec951b	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077068 application number: ANDA077068
Baclofen	BACLOFEN	Par Health USA, LLC	c17527be-661d-42f5-b6f6-56a681ba7870	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077068 application number: ANDA077068

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
197391	baclofen 10 MG Oral Tablet	PSN	0308ca55-2461-4500-8e35-1d26282d3679	2
197392	baclofen 20 MG Oral Tablet	PSN	0308ca55-2461-4500-8e35-1d26282d3679	2
197391	baclofen 10 MG Oral Tablet	SCD	0308ca55-2461-4500-8e35-1d26282d3679	2
197392	baclofen 20 MG Oral Tablet	SCD	0308ca55-2461-4500-8e35-1d26282d3679	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0889-1	53808088901	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN TABLETS, USP	State of Florida DOH Central Pharmacy	2014-10-08	HUMAN PRESCRIPTION DRUG LABEL	2