Indomethacin

Product NDC
60760-916
11-digit product format
607600916
Labeler code
60760
Product ID
60760-916_43cff215-ee28-4b44-e063-6394a90a8a11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA091240
Marketing category
ANDA
Marketing start
2016-05-19
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
60760-916-21Indomethacin21 in 1 BOTTLE, PLASTICCAPSULE213
60760-916-30Indomethacin30 in 1 BOTTLE, PLASTICCAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-916-21EA - Each60760-9164b9f1f63-dbfa-48b7-b8a6-926efe2794e112025-05-14
60760-916-30EA - Each60760-9164665bc3f-1332-424f-9358-a8bcb1d2b32812024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-916INDOMETHACIN CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, 2 package rows20250305_205fc4e7-e118-509e-e063-6394a90a78e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN205fc4e7-e118-509e-e063-6394a90a78e63
197818indomethacin 50 MG Oral CapsuleSCD205fc4e7-e118-509e-e063-6394a90a78e63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-916-216076009162121 CAPSULE in 1 BOTTLE, PLASTIC (60760-916-21) 21 capsule2025-02-28NoNoCurrent
60760-916-306076009163030 CAPSULE in 1 BOTTLE, PLASTIC (60760-916-30) 30 capsule2024-08-21NoNoCurrent