Indomethacin

Product NDC
31722-051
11-digit product format
317220051
Labeler code
31722
Product ID
31722-051_3de4c874-6157-dc17-e063-6394a90a7ae2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA216905
Marketing category
ANDA
Marketing start
2025-07-03
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
Rxcui197819

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-051-31Indomethacin30 in 1 CARTONSUPPOSITORY301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-051-31EA - Each31722-051032c4539-c1e5-4878-9bcd-3304d8cf6fb912025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197819indomethacin 50 MG Rectal SuppositoryPSNc81343f2-5ef5-4635-9b94-5ac8d72aa61e1
197819indomethacin 50 MG Rectal SuppositorySCDc81343f2-5ef5-4635-9b94-5ac8d72aa61e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-051-313172200513130 SUPPOSITORY in 1 CARTON (31722-051-31) 30 suppository2025-07-03NoNoHistorical