Baclofen

Product NDC: 66336-486
11-digit product format: 663360486
Labeler code: 66336
Product ID: 66336-486_9b60cb0d-4259-49dc-8b29-0dcf504cf40f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA077068
Marketing category: ANDA
Marketing start: 2005-08-30
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: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	66336-486		I	Inactivated by FDA		2026-08-03
excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 38 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	66336-486		I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	66336-486	66336-486-94	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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
66336-486-94	2019-11-27	C162847	48780-1	9855d018-da4b-cd31-e053-dbdaa90ab51a	BACLOFEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66336-486-94	Baclofen	120 in 1 BOTTLE, PLASTIC	TABLET	120		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66336-486	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 1 package rows	20130803_2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda.zip

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	2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda	1
197392	baclofen 20 MG Oral Tablet	PSN	2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda	1
197391	baclofen 10 MG Oral Tablet	SCD	2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda	1
197392	baclofen 20 MG Oral Tablet	SCD	2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66336-486-94	66336048694	120 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN TABLETS, USP	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-08-02	HUMAN PRESCRIPTION DRUG LABEL	1