FDA.reportPublic FDA data

Baclofen

Product NDC
16714-071
11-digit product format
167140071
Labeler code
16714
Product ID
16714-071_a3881489-a033-4a93-ba24-590e316103f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Northstar RxLLC
Application
ANDA078401
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

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 Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197391, 197392

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
16714-071-04Baclofen100 in 1 BOTTLETABLET10017
16714-071-06Baclofen1000 in 1 BOTTLETABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-071-04EA - Each16714-071c5e32c0b-3f95-4a08-af31-1e85cf63be9412012-07-24
16714-071-06EA - Each16714-071167d92a1-1f1b-4f7c-b235-66216ba8360912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BaclofenACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [NORTHSTAR RXLLC]11
BaclofenACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [NORTHSTAR RXLLC]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [NORTHSTAR RXLLC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [NORTHSTAR RXLLC]11
POVIDONE K30INACTIVE INGREDIENTU725QWY32XBACLOFEN TABLET [NORTHSTAR RXLLC]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [NORTHSTAR RXLLC]11
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TBACLOFEN TABLET [NORTHSTAR RXLLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-071BACLOFEN TABLET [NORTHSTAR RXLLC]16Current NDC, Legacy NDC, 2 package rows20250409_0aac77fa-30c2-46c8-a04d-e6b8333ddd81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN0aac77fa-30c2-46c8-a04d-e6b8333ddd8117
197392baclofen 20 MG Oral TabletPSN0aac77fa-30c2-46c8-a04d-e6b8333ddd8117
197391baclofen 10 MG Oral TabletSCD0aac77fa-30c2-46c8-a04d-e6b8333ddd8117
197392baclofen 20 MG Oral TabletSCD0aac77fa-30c2-46c8-a04d-e6b8333ddd8117
197391baclofen 10 MG Oral TabletPSNb65d3089-0412-487f-a1b4-66f0bc6f398e5
197391baclofen 10 MG Oral TabletSCDb65d3089-0412-487f-a1b4-66f0bc6f398e5
197391baclofen 10 MG Oral TabletPSN7ee42a29-21c2-47f8-a5b3-f3af115b665d1
197391baclofen 10 MG Oral TabletSCD7ee42a29-21c2-47f8-a5b3-f3af115b665d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-071-0416714007104100 TABLET in 1 BOTTLE (16714-071-04) 100 tablet2011-01-010000-00-00NoNoCurrent
16714-071-06167140071061000 TABLET in 1 BOTTLE (16714-071-06) 1000 tablet2011-01-010000-00-00NoNoCurrent