FDA.reportPublic FDA data

Mefenamic Acid

Product NDC
80425-0306
11-digit product format
804250306
Labeler code
80425
Product ID
80425-0306_2a9ba8f4-6cef-e827-e063-6394a90a0300
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mefenamic Acid
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA090562
Marketing category
ANDA
Marketing start
2023-04-06
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
80425-0306-1Mefenamic Acid30 in 1 BOTTLECAPSULE302
80425-0306-2Mefenamic Acid60 in 1 BOTTLECAPSULE602
80425-0306-3Mefenamic Acid90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0306-1EA - Each80425-0306dcf74e20-fdb3-4393-b80f-bb34e649da6112023-06-06
80425-0306-2EA - Each80425-03060680efaa-6c6c-47df-9f0e-47ebdc0851fd12023-06-06
80425-0306-3EA - Each80425-0306f88b4fa9-824f-4606-9931-d7c5f3c6eceb12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0306MEFENAMIC ACID CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8b1a4a2-83fc-6b4b-e053-6394a90ac46a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829500mefenamic acid 250 MG Oral CapsulePSNf8b1a4a2-83fc-6b4b-e053-6394a90ac46a2
829500mefenamic acid 250 MG Oral CapsuleSCDf8b1a4a2-83fc-6b4b-e053-6394a90ac46a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0306-18042503060130 CAPSULE in 1 BOTTLE (80425-0306-1) 30 capsule2023-04-06NoNoHistorical
80425-0306-28042503060260 CAPSULE in 1 BOTTLE (80425-0306-2) 60 capsule2023-04-06NoNoHistorical
80425-0306-38042503060390 CAPSULE in 1 BOTTLE (80425-0306-3) 90 capsule2023-04-06NoNoHistorical