Indomethacin

Product NDC
63187-282
11-digit product format
631870282
Labeler code
63187
Product ID
63187-282_21bbc489-2478-48dc-b70b-16bc5f8779c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091240
Marketing category
ANDA
Marketing start
2011-11-01
Substance
INDOMETHACIN
Active strength
50 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
Indomethacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDOMETHACIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXXE1CET956
Rxcui197818

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-282-08Indomethacin08 in 1 BOTTLECAPSULE086
63187-282-15Indomethacin15 in 1 BOTTLECAPSULE156
63187-282-30Indomethacin30 in 1 BOTTLECAPSULE306
63187-282-60Indomethacin60 in 1 BOTTLECAPSULE606
63187-282-90Indomethacin90 in 1 BOTTLECAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-282-30EA - Each63187-28256cae591-8e8c-4808-aea3-02a2e7904b2012016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [PROFICIENT RX LP]2
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [PROFICIENT RX LP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [PROFICIENT RX LP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [PROFICIENT RX LP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [PROFICIENT RX LP]2
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [PROFICIENT RX LP]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-282INDOMETHACIN CAPSULE [PROFICIENT RX LP]6Current NDC, Legacy NDC, 5 package rows20230124_66e3205b-eab1-4864-bf36-116e9d79fe3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN66e3205b-eab1-4864-bf36-116e9d79fe3e6
197818indomethacin 50 MG Oral CapsuleSCD66e3205b-eab1-4864-bf36-116e9d79fe3e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-282-08631870282088 CAPSULE in 1 BOTTLE (63187-282-08) 8 capsule2019-01-010000-00-00NoNoCurrent
63187-282-156318702821515 CAPSULE in 1 BOTTLE (63187-282-15) 15 capsule2019-01-010000-00-00NoNoCurrent
63187-282-306318702823030 CAPSULE in 1 BOTTLE (63187-282-30) 30 capsule2019-01-010000-00-00NoNoCurrent
63187-282-606318702826060 CAPSULE in 1 BOTTLE (63187-282-60) 60 capsule2019-01-010000-00-00NoNoCurrent
63187-282-906318702829090 CAPSULE in 1 BOTTLE (63187-282-90) 90 capsule2019-01-010000-00-00NoNoCurrent