BACLOFEN

Product NDC: 73352-103
11-digit product format: 733520103
Labeler code: 73352
Product ID: 73352-103_3a73197c-59cf-621b-e063-6394a90a955b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: SOLUTION
Route: ORAL
Labeler: Trifluent Pharma, LLC
Application: ANDA214445
Marketing category: ANDA
Marketing start: 2025-06-05
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: 2026-12-31
Current FDA listing: Yes

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
A214445-001	BACLOFEN	BACLOFEN	5MG/5ML	SOLUTION / ORAL			2024-12-06
A214445-002	BACLOFEN	BACLOFEN	10MG/5ML	SOLUTION / ORAL	AA		2025-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214445-002	AA

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.

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	A214445-001	BACLOFEN	5MG/5ML	SOLUTION / ORAL		2024-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214445-002	BACLOFEN	10MG/5ML	SOLUTION / ORAL	AA	2025-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214445-001	BACLOFEN	5MG/5ML	SOLUTION / ORAL		2024-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214445-002	BACLOFEN	10MG/5ML	SOLUTION / ORAL	AA	2025-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214445-001	BACLOFEN	5MG/5ML	SOLUTION / ORAL		2024-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214445-002	BACLOFEN	10MG/5ML	SOLUTION / ORAL	AA	2025-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214445-001	BACLOFEN	5MG/5ML	SOLUTION / ORAL		2024-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214445-001	BACLOFEN	5MG/5ML	SOLUTION / ORAL		2024-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214445-001	BACLOFEN	5MG/5ML	SOLUTION / ORAL		2024-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214445-001	BACLOFEN	5MG/5ML	SOLUTION / ORAL		2024-12-06	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214445-001	BACLOFEN	5MG/5ML	SOLUTION / ORAL		2024-12-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214445-002	BACLOFEN	10MG/5ML	SOLUTION / ORAL	AA	2025-06-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214445-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214445-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214445-002	AA	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214445-002	AA	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214445-001	PC	2025-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214445-001	PC	2025-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214445-001	PC	2025-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214445-001	PC	2025-07-14	`b8a1b40f171c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACLOFEN	5 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
250976	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
890df151-f4eb-4244-97c4-f1f10912e753	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
73352-103-16	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
73352-103-16	ML - Milliliter	73352-103	6ab2f789-8554-409d-9336-bc5163d44819	1	2025-08-11

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	Trifluent Pharma, LLC	890df151-f4eb-4244-97c4-f1f10912e753	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214445 application number: ANDA214445 ndc (product): 73352-103
BACLOFEN	BACLOFEN	Advagen Pharma Ltd	2a43830f-a28b-ca15-e063-6294a90a6b1a	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214445 application number: ANDA214445
Baclofen	BACLOFEN	Advagen Pharma Ltd.,	75ab298b-b2a7-458f-accc-5bfc89b89a16	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214445 application number: ANDA214445

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	890df151-f4eb-4244-97c4-f1f10912e753	2
250976	baclofen 1 MG/ML Oral Solution	SCD	890df151-f4eb-4244-97c4-f1f10912e753	2
250976	baclofen 5 MG per 5 mL Oral Solution	SY	890df151-f4eb-4244-97c4-f1f10912e753	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73352-103-16	73352010316	473 mL in 1 BOTTLE (73352-103-16)	473 ml	2025-06-05	No	No	Current