FDA.reportPublic FDA data

Indomethacin

Product NDC
0378-0143
11-digit product format
003780143
Labeler code
0378
Product ID
0378-0143_1c722370-d051-4f78-8775-1e37c5eda55d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA018858
Marketing category
NDA
Marketing start
1984-04-20
Marketing end
2019-07-31
Substance
INDOMETHACIN
Active strength
25 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0143-01EA - Each0378-0143ef22332e-136a-459b-be56-10ed5bef966912012-07-24
0378-0143-10EA - Each0378-0143cf230bfd-d9d4-4f19-bc49-5b92fcb59f4412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN58ae8e0c-5555-4702-a61f-dde7d396a6db2
197818indomethacin 50 MG Oral CapsulePSN58ae8e0c-5555-4702-a61f-dde7d396a6db2
197817indomethacin 25 MG Oral CapsuleSCD58ae8e0c-5555-4702-a61f-dde7d396a6db2
197818indomethacin 50 MG Oral CapsuleSCD58ae8e0c-5555-4702-a61f-dde7d396a6db2