FDA.reportPublic FDA data

Baclofen

Product NDC
63629-3193
11-digit product format
636293193
Labeler code
63629
Product ID
63629-3193_bf500d4b-4dd6-4710-85fa-b62096912c24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
No
Listing certified through
2020-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-3193DDiscontinued by firm2026-08-03
excluded packagepackage63629-319363629-3193-0DDiscontinued by firm2026-08-03
excluded packagepackage63629-319363629-3193-1DDiscontinued by firm2026-08-03
excluded packagepackage63629-319363629-3193-2DDiscontinued by firm2026-08-03
excluded packagepackage63629-319363629-3193-3DDiscontinued by firm2026-08-03
excluded packagepackage63629-319363629-3193-4DDiscontinued by firm2026-08-03
excluded packagepackage63629-319363629-3193-5DDiscontinued by firm2026-08-03
excluded packagepackage63629-319363629-3193-6DDiscontinued by firm2026-08-03
excluded packagepackage63629-319363629-3193-7DDiscontinued by firm2026-08-03
excluded packagepackage63629-319363629-3193-8DDiscontinued by firm2026-08-03
excluded packagepackage63629-319363629-3193-9DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077068-001BACLOFENBACLOFEN20MGTABLET / ORALAB2005-08-30
A077068-002BACLOFENBACLOFEN10MGTABLET / ORALAB2005-08-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077068-001AB
A077068-002AB

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 22:54:322026-06A077068-001BACLOFEN20MGTABLET / ORALAB2005-08-30a50c72e98297…
2026-08-01 22:54:322026-06A077068-002BACLOFEN10MGTABLET / ORALAB2005-08-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077068-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077068-002AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENBryant Ranch Prepack7b6d33d8-58c2-448d-a8df-1de7339b15202024-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077068
application number: ANDA077068
BaclofenBACLOFENBryant Ranch Prepack4cbb2264-ef65-4906-86e5-349deeeda7a92024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077068
application number: ANDA077068
BaclofenBACLOFENBryant Ranch Prepack32525b4e-6384-49e1-a66d-abe45484ab862024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077068
application number: ANDA077068
BaclofenBACLOFENBryant Ranch Prepacke13c0563-0f32-4199-acb0-ad2376ec951b2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077068
application number: ANDA077068
BaclofenBACLOFENPar Health USA, LLCc17527be-661d-42f5-b6f6-56a681ba78702024-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077068
application number: ANDA077068

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3193-0EA - Each63629-319323b04d58-82a8-4b1e-a444-e036b47660fd12019-05-02
63629-3193-1EA - Each63629-3193d3dbec37-a51f-4748-83cc-22fe50e0e5a912012-07-24
63629-3193-2EA - Each63629-319366f79331-a15f-4082-b40d-76e47372d5d612012-07-24
63629-3193-3EA - Each63629-3193c0699e0b-255f-49b5-891e-06c4e33ed32712012-07-24
63629-3193-4EA - Each63629-319333f03c2e-c57c-4fc7-95d2-ed3d0ff70ffb12012-07-24
63629-3193-5EA - Each63629-3193cb728474-3b0d-4735-a1b2-4ec7ecb88af212012-07-24
63629-3193-6EA - Each63629-319358fb7f40-b612-4e56-a8ba-c1e8badd8a0912012-07-24
63629-3193-7EA - Each63629-31933ac61397-b534-4344-b63b-bf87c0f95a3612012-07-24
63629-3193-8EA - Each63629-31930b3747c5-5239-4eeb-a737-0185f34c152512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BaclofenACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [BRYANT RANCH RREPACK]4
BaclofenACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [BRYANT RANCH RREPACK]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [BRYANT RANCH RREPACK]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBACLOFEN TABLET [BRYANT RANCH RREPACK]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [BRYANT RANCH RREPACK]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [BRYANT RANCH RREPACK]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [BRYANT RANCH RREPACK]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3193-063629319300120 TABLET in 1 BOTTLE, PLASTIC (63629-3193-0) 120 tablet2005-08-300000-00-00NoNoCurrent
63629-3193-16362931930190 TABLET in 1 BOTTLE, PLASTIC (63629-3193-1) 90 tablet2005-08-300000-00-00NoNoCurrent
63629-3193-26362931930220 TABLET in 1 BOTTLE, PLASTIC (63629-3193-2) 20 tablet2005-08-300000-00-00NoNoCurrent
63629-3193-36362931930360 TABLET in 1 BOTTLE, PLASTIC (63629-3193-3) 60 tablet2005-08-300000-00-00NoNoCurrent
63629-3193-46362931930445 TABLET in 1 BOTTLE, PLASTIC (63629-3193-4) 45 tablet2005-08-300000-00-00NoNoCurrent
63629-3193-563629319305112 TABLET in 1 BOTTLE, PLASTIC (63629-3193-5) 112 tablet2005-08-300000-00-00NoNoCurrent
63629-3193-66362931930630 TABLET in 1 BOTTLE, PLASTIC (63629-3193-6) 30 tablet2005-08-300000-00-00NoNoCurrent
63629-3193-76362931930756 TABLET in 1 BOTTLE, PLASTIC (63629-3193-7) 56 tablet2005-08-300000-00-00NoNoCurrent
63629-3193-86362931930815 TABLET in 1 BOTTLE, PLASTIC (63629-3193-8) 15 tablet2005-08-300000-00-00NoNoCurrent
63629-3193-96362931930984 TABLET in 1 BOTTLE, PLASTIC (63629-3193-9) 84 tablet2005-08-300000-00-00NoNoCurrent