FDA.reportPublic FDA data

Baclofen

Product NDC
71205-474
Requested package NDC
71205-474-14
11-digit product format
712050474
Labeler code
71205
Product ID
71205-474_4702c59e-202c-4900-9388-f64788cb035c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078504
Marketing category
ANDA
Marketing start
2011-01-01
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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
b65d3089-0412-487f-a1b4-66f0bc6f398eAvailable 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
71205-474-14Baclofen14 in 1 BOTTLETABLET145
71205-474-20Baclofen20 in 1 BOTTLETABLET205
71205-474-30Baclofen30 in 1 BOTTLETABLET305
71205-474-60Baclofen60 in 1 BOTTLETABLET605
71205-474-72Baclofen120 in 1 BOTTLETABLET1205
71205-474-78Baclofen180 in 1 BOTTLETABLET1805
71205-474-90Baclofen90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-474-14EA - Each71205-47470875bfa-8d97-4d07-b6c6-b368179533d212022-03-09
71205-474-72EA - Each71205-4741932362e-1ae4-41b6-a367-e60438f8d5f912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-474BACLOFEN TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 7 package rows20220409_b65d3089-0412-487f-a1b4-66f0bc6f398e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENProficient Rx LPb65d3089-0412-487f-a1b4-66f0bc6f398e2022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078504
application number: ANDA078504
ndc (package): 71205-474-14
ndc (product): 71205-474
ndc11 (package): 71205047414

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNb65d3089-0412-487f-a1b4-66f0bc6f398e5
197391baclofen 10 MG Oral TabletSCDb65d3089-0412-487f-a1b4-66f0bc6f398e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-474-147120504741414 TABLET in 1 BOTTLE (71205-474-14) 14 tablet2022-01-050000-00-00NoNoCurrent