Indomethacin

Product NDC
70518-1458
11-digit product format
705181458
Labeler code
70518
Product ID
70518-1458_507111cb-975a-27ba-e063-6294a90a102c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091276
Marketing category
ANDA
Marketing start
2018-10-03
Substance
INDOMETHACIN
Active strength
25 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
Indomethacin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDOMETHACIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXXE1CET956
Rxcui197817

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
70518-1458-0Indomethacin30 in 1 BLISTER PACKCAPSULE3014
70518-1458-1Indomethacin50 in 1 BOXCAPSULE5014
70518-1458-2Indomethacin1 in 1 POUCHCAPSULE114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1458INDOMETHACIN CAPSULE [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250223_16238287-d4b0-4afa-8483-1f4ae250a625.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN16238287-d4b0-4afa-8483-1f4ae250a62514
197817indomethacin 25 MG Oral CapsuleSCD16238287-d4b0-4afa-8483-1f4ae250a62514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1458-07051814580030 CAPSULE in 1 BLISTER PACK (70518-1458-0) 30 capsule2018-10-030000-00-00NoNoCurrent
70518-1458-17051814580150 POUCH in 1 BOX (70518-1458-1) / 1 CAPSULE in 1 POUCH (70518-1458-2) 50 pouch2026-04-24NoNoCurrent
70518-1458-2705181458021 in 1 POUCHHistorical