FDA.reportPublic FDA data

Baclofen

Product NDC
67046-1072
11-digit product format
670461072
Labeler code
67046
Product ID
67046-1072_5023daca-e46c-c225-e063-6394a90ab41b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA211659
Marketing category
ANDA
Marketing start
2026-04-23
Substance
BACLOFEN
Active strength
10 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
2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211659-001BACLOFENBACLOFEN10MGTABLET / ORALAB2018-11-23
A211659-002BACLOFENBACLOFEN20MGTABLET / ORALAB2018-11-23
A211659-003BACLOFENBACLOFEN5MGTABLET / ORALAB2020-04-17
A211659-004BACLOFENBACLOFEN15MGTABLET / ORALAB2024-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A211659-001AB
A211659-002AB
A211659-003AB
A211659-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211659-001BACLOFEN10MGTABLET / ORALAB2018-11-23a50c72e98297…
2026-08-01 22:54:322026-06A211659-002BACLOFEN20MGTABLET / ORALAB2018-11-23a50c72e98297…
2026-08-01 22:54:322026-06A211659-003BACLOFEN5MGTABLET / ORALAB2020-04-17a50c72e98297…
2026-08-01 22:54:322026-06A211659-004BACLOFEN15MGTABLET / ORALAB2024-02-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211659-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A211659-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A211659-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A211659-004AB1a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENCardinal Health 107, LLC3c87e116-871d-46b8-897b-fc27a17b988d2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211659
application number: ANDA211659
BaclofenBACLOFENAvPAKc21095a9-17b1-555a-e053-2a95a90a51fd2026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211659
application number: ANDA211659
BaclofenBACLOFENAvPAKbc9040d9-1c54-9d62-e053-2a95a90a6ae32026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211659
application number: ANDA211659
BaclofenBACLOFENCoupler LLC5023c690-fd86-bb7d-e063-6394a90af6cd2026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211659
application number: ANDA211659
ndc (product): 67046-1072
BaclofenBACLOFENA-S Medication Solutions4f84b27a-725a-48e6-a58a-85bbb395f4ae2026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211659
application number: ANDA211659
BaclofenBACLOFENA-S Medication Solutions5f6a86f9-9658-4210-a47c-62907edfd4162026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211659
application number: ANDA211659
BaclofenBACLOFENA-S Medication Solutions975fda6d-d929-482b-8be7-60849026dbdd2026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211659
application number: ANDA211659
BaclofenBACLOFENAmerican Health Packaging8b046ee6-28fc-4ab1-b543-414ad0103e5c2025-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211659
application number: ANDA211659
BaclofenBACLOFENBryant Ranch Prepack5b92b0a6-ebba-4815-8b94-f2014674399b2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211659
application number: ANDA211659
BaclofenBACLOFENZydus Lifesciences Limitedbb5c6faa-2933-44d1-8706-8302150be7342024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211659
application number: ANDA211659
BaclofenBACLOFENZydus Pharmaceuticals (USA) Inc.cfc49176-8d01-4c39-9319-604dd087065c2024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211659
application number: ANDA211659

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H789N3FKE8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197391Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5023c690-fd86-bb7d-e063-6394a90af6cdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1072-3Baclofen30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN5023c690-fd86-bb7d-e063-6394a90af6cd1
197391baclofen 10 MG Oral TabletSCD5023c690-fd86-bb7d-e063-6394a90af6cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1072-36704610720330 TABLET in 1 BLISTER PACK (67046-1072-3) 30 tablet2026-04-23NoNoCurrent