FDA.reportPublic FDA data

Baclofen

Product NDC
72834-602
11-digit product format
728340602
Labeler code
72834
Product ID
72834-602_47e27e4a-5ce3-113b-e063-6394a90a363d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
SOLUTION
Route
ORAL
Labeler
Sarras Health LLC
Application
NDA208193
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-03-05
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
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208193-001OZOBAXBACLOFEN5MG/5MLSOLUTION / ORALRLD2019-09-18
N208193-002OZOBAX DSBACLOFEN10MG/5MLSOLUTION / ORALAARLD, RS2023-10-12

Therapeutic equivalence codes#

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

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

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208193-001106105022039-08-30U-27792020-04-23

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N208193-001OZOBAX5MG/5MLSOLUTION / ORALRLD2019-09-18a50c72e98297…
2026-08-01 22:54:322026-06N208193-002OZOBAX DS10MG/5MLSOLUTION / ORALAARLD, RS2023-10-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N208193-002AA1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N208193-001106105022039-08-30U-27792020-04-23a50c72e98297…

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
BaclofenBACLOFENAtlantic Biologicals Corp.50b3e7be-832b-313d-e063-6394a90a5ab42026-07-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 208193
application number: NDA208193
BaclofenBACLOFENRosemont Pharmaceuticals LLC81a539b3-e547-4a62-ad1b-2eedb30be9272026-03-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 208193
application number: NDA208193
ndc (product): 72834-602
OZOBAX DSBACLOFENRosemont Pharmaceuticals LLCd8ddcec5-debe-42b4-a803-e65917cc6a542026-03-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 208193
application number: NDA208193
BaclofenBACLOFENPalmetto Pharmaceuticals Inc.2422746c-afec-ad30-e063-6394a90a04032025-12-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 208193
application number: NDA208193
BaclofenBACLOFENTRUPHARMA, LLCf8ec79c6-da65-4fb6-b6bd-45df0d2a52c72023-10-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 208193
application number: NDA208193

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN10 mg/5mL

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
2667941Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
81a539b3-e547-4a62-ad1b-2eedb30be927Available 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
72834-602-16Baclofen473 mL in 1 BOTTLESOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72834-602-16ML - Milliliter72834-602da40df2c-a544-4fbe-8936-0d52c0f8e8da12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72834-602BACLOFEN SOLUTION [SARRAS HEALTH LLC]1Current NDC, 1 package rows20240307_81a539b3-e547-4a62-ad1b-2eedb30be927.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667941baclofen 10 MG in 5 mL Oral SolutionPSN81a539b3-e547-4a62-ad1b-2eedb30be9272
2667941baclofen 2 MG/ML Oral SolutionSCD81a539b3-e547-4a62-ad1b-2eedb30be9272
2667941baclofen 10 MG per 5 mL Oral SolutionSY81a539b3-e547-4a62-ad1b-2eedb30be9272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72834-602-1672834060216473 mL in 1 BOTTLE (72834-602-16) 473 ml2024-03-05NoNoCurrent