FDA.reportPublic FDA data

INDOMETHACIN

Product NDC
71335-9754
11-digit product format
713359754
Labeler code
71335
Product ID
71335-9754_6f8b687c-33f2-4936-ac92-aceadb1a90ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079175
Marketing category
ANDA
Marketing start
2009-03-06
Substance
INDOMETHACIN
Active strength
75 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
INDOMETHACIN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXXE1CET956
Rxcui310992

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9754-1INDOMETHACIN30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30104
71335-9754-2INDOMETHACIN60 in 1 BOTTLECAPSULE, EXTENDED RELEASE60104
71335-9754-3INDOMETHACIN14 in 1 BOTTLECAPSULE, EXTENDED RELEASE14104
71335-9754-4INDOMETHACIN10 in 1 BOTTLECAPSULE, EXTENDED RELEASE10104
71335-9754-5INDOMETHACIN7 in 1 BOTTLECAPSULE, EXTENDED RELEASE7104
71335-9754-6INDOMETHACIN15 in 1 BOTTLECAPSULE, EXTENDED RELEASE15104
71335-9754-7INDOMETHACIN20 in 1 BOTTLECAPSULE, EXTENDED RELEASE20104
71335-9754-8INDOMETHACIN90 in 1 BOTTLECAPSULE, EXTENDED RELEASE90104
71335-9754-9INDOMETHACIN100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9754INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, 9 package rows20250519_41af7776-36bc-4820-b635-e7c69f26997e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSN41af7776-36bc-4820-b635-e7c69f26997e104
310992indomethacin 75 MG Extended Release Oral CapsuleSCD41af7776-36bc-4820-b635-e7c69f26997e104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9754-17133597540130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-1) 2023-09-21NoNoHistorical
71335-9754-27133597540260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-2) 2024-04-09NoNoHistorical
71335-9754-37133597540314 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-3) 2023-08-01NoNoHistorical
71335-9754-47133597540410 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-4) 2024-04-09NoNoHistorical
71335-9754-5713359754057 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-5) 2024-04-09NoNoHistorical
71335-9754-67133597540615 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-6) 2024-04-09NoNoHistorical
71335-9754-77133597540720 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-7) 2024-04-09NoNoHistorical
71335-9754-87133597540890 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-8) 2024-04-09NoNoHistorical
71335-9754-971335975409100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-9) 2024-04-09NoNoHistorical