Baclofen

Product NDC: 52817-620
11-digit product format: 528170620
Labeler code: 52817
Product ID: 52817-620_0806a6f9-b626-f98e-e063-6294a90a84bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: SOLUTION
Route: ORAL
Labeler: TRUPHARMA, LLC
Application: NDA208193
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2023-10-12
Substance: BACLOFEN
Active strength: 10 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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Baclofen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACLOFEN	10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
H789N3FKE8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2667941	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7	Available on FDA.report

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
52817-620-08	Baclofen	237 mL in 1 BOTTLE	SOLUTION	237		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52817-620	BACLOFEN SOLUTION [TRUPHARMA, LLC]	1	Current NDC, 1 package rows	20231019_f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7.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 ndc (product): 52817-620

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
2667941	baclofen 10 MG in 5 mL Oral Solution	PSN	50b3e7be-832b-313d-e063-6394a90a5ab4	2
2667941	baclofen 2 MG/ML Oral Solution	SCD	50b3e7be-832b-313d-e063-6394a90a5ab4	2
2667941	baclofen 10 MG per 5 mL Oral Solution	SY	50b3e7be-832b-313d-e063-6394a90a5ab4	2
2667941	baclofen 10 MG in 5 mL Oral Solution	PSN	f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7	1
2667941	baclofen 2 MG/ML Oral Solution	SCD	f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7	1
2667941	baclofen 10 MG per 5 mL Oral Solution	SY	f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
52817-620-08	52817062008	237 mL in 1 BOTTLE (52817-620-08)	237 ml	2023-10-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen	Atlantic Biologicals Corp.	2026-08-21	HUMAN PRESCRIPTION DRUG LABEL	5
Baclofen	TRUPHARMA, LLC	2023-10-18	HUMAN PRESCRIPTION DRUG LABEL	1