Mefenamic Acid

Product NDC
68180-185
11-digit product format
681800185
Labeler code
68180
Product ID
68180-185_3e8cdf69-7610-4745-a6b6-0d3d0af09867
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mefenamic Acid
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA091322
Marketing category
ANDA
Marketing start
2011-09-06
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
68180-185-01Mefenamic Acid100 in 1 BOTTLECAPSULE10013
68180-185-06Mefenamic Acid30 in 1 BOTTLECAPSULE3013
68180-185-11Mefenamic Acid8 in 1 BLISTER PACKCAPSULE813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-185-06EA - Each68180-185350a23cb-987a-45e7-9ede-21040235df2512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEFENAMIC ACIDACTIVE INGREDIENT367589PJ2CMEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
MEFENAMIC ACIDACTIVE MOIETY367589PJ2CMEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYMEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
GELATININACTIVE INGREDIENT2G86QN327LMEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
SHELLACINACTIVE INGREDIENT46N107B71OMEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-185MEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 3 package rows20240120_d15733a9-d5fd-4d5f-86ce-e7ed8c706c7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829500mefenamic acid 250 MG Oral CapsulePSNd15733a9-d5fd-4d5f-86ce-e7ed8c706c7f13
829500mefenamic acid 250 MG Oral CapsuleSCDd15733a9-d5fd-4d5f-86ce-e7ed8c706c7f13
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 startMarketing endSampleExclude flagStatus
68180-185-0168180018501100 CAPSULE in 1 BOTTLE (68180-185-01) 100 capsule2011-09-060000-00-00NoNoCurrent
68180-185-066818001850630 CAPSULE in 1 BOTTLE (68180-185-06) 30 capsule2011-09-060000-00-00NoNoCurrent
68180-185-11681800185118 in 1 BLISTER PACKHistorical
68180-185-13681800185133 BLISTER PACK in 1 CARTON (68180-185-13) > 8 CAPSULE in 1 BLISTER PACK (68180-185-11) 3 blister pack2011-09-060000-00-00NoNoCurrent