FDA.reportPublic FDA data

Mefenamic Acid

Product NDC
80425-0423
11-digit product format
804250423
Labeler code
80425
Product ID
80425-0423_1e927779-411b-b5f5-e063-6394a90aae93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mefenamic Acid
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA091322
Marketing category
ANDA
Marketing start
2024-07-19
Substance
MEFENAMIC ACID
Active strength
250 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mefenamic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEFENAMIC ACID250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii367589PJ2C
Rxcui829500

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4e49f7b3-969c-15d1-c46f-04e94dac5598Product name220150108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0423-1Mefenamic Acid30 in 1 BOTTLECAPSULE301
80425-0423-2Mefenamic Acid60 in 1 BOTTLECAPSULE601
80425-0423-3Mefenamic Acid90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0423-1EA - Each80425-0423c6fa5e3f-6582-4834-b971-819ccbcf338e12024-09-09
80425-0423-2EA - Each80425-0423879a29b6-5993-4935-963a-8ebd45161a7e12024-09-09
80425-0423-3EA - Each80425-042312d747ec-b8c9-484e-a923-0ed2186c909c12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0423MEFENAMIC ACID CAPSULE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20240802_1e927779-411a-b5f5-e063-6394a90aae93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829500mefenamic acid 250 MG Oral CapsulePSN1e927779-411a-b5f5-e063-6394a90aae931
829500mefenamic acid 250 MG Oral CapsuleSCD1e927779-411a-b5f5-e063-6394a90aae931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0423-18042504230130 CAPSULE in 1 BOTTLE (80425-0423-1) 30 capsule2024-07-19NoNoCurrent
80425-0423-28042504230260 CAPSULE in 1 BOTTLE (80425-0423-2) 60 capsule2024-07-19NoNoCurrent
80425-0423-38042504230390 CAPSULE in 1 BOTTLE (80425-0423-3) 90 capsule2024-07-19NoNoCurrent