BACLOFEN

Product NDC: 68134-401
11-digit product format: 681340401
Labeler code: 68134
Product ID: 68134-401_db4788b4-a23c-5ed7-e053-2995a90a48d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: SOLUTION
Route: ORAL
Labeler: Palmetto Pharmaceuticals Inc.
Application: NDA208193
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2022-03-15
Marketing end: 0000-00-00
Substance: BACLOFEN
Active strength: 5 mg/5mL
Pharmacologic classes: GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68134-401		I	Inactivated by FDA		2026-08-17
excluded package	package	68134-401	68134-401-16	I	Inactivated by FDA		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N208193-001	OZOBAX	BACLOFEN	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18
N208193-002	OZOBAX DS	BACLOFEN	10MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2023-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208193-002	AA

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208193-001	10610502	2039-08-30	U-2779		2020-04-23

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 2 · 59 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2023-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2023-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2023-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2023-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N208193-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208193-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208193-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208193-002	AA	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208193-002	AA	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`a50c72e98297…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68134-401-16	BACLOFEN	473 mL in 1 BOTTLE	SOLUTION	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68134-401-16	ML - Milliliter	68134-401	7f8c3507-a5f3-4bd3-9846-b041c33fda6c	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68134-401	BACLOFEN SOLUTION [PALMETTO PHARMACEUTICALS INC.]	2	Legacy NDC, 1 package rows	20220329_6cc2773b-cb64-48e9-a69b-e457b82cb2d4.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	Atlantic Biologicals Corp.	50b3e7be-832b-313d-e063-6394a90a5ab4	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208193 application number: NDA208193
Baclofen	BACLOFEN	Rosemont Pharmaceuticals LLC	81a539b3-e547-4a62-ad1b-2eedb30be927	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208193 application number: NDA208193
OZOBAX DS	BACLOFEN	Rosemont Pharmaceuticals LLC	d8ddcec5-debe-42b4-a803-e65917cc6a54	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208193 application number: NDA208193
Baclofen	BACLOFEN	Palmetto Pharmaceuticals Inc.	2422746c-afec-ad30-e063-6394a90a0403	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208193 application number: NDA208193
Baclofen	BACLOFEN	TRUPHARMA, LLC	f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208193 application number: NDA208193

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
250976	baclofen 5 MG in 5 mL Oral Solution	PSN	6cc2773b-cb64-48e9-a69b-e457b82cb2d4	2
250976	baclofen 1 MG/ML Oral Solution	SCD	6cc2773b-cb64-48e9-a69b-e457b82cb2d4	2
250976	baclofen 5 MG per 5 mL Oral Solution	SY	6cc2773b-cb64-48e9-a69b-e457b82cb2d4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68134-401-16	68134040116	473 mL in 1 BOTTLE (68134-401-16)	473 ml	2022-03-15	0000-00-00	No	No	Current