FDA.reportPublic FDA data

Indomethacin

Product NDC
71205-159
11-digit product format
712050159
Labeler code
71205
Product ID
71205-159_7cf20748-c6be-4b66-9f17-9455d88c997d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091276
Marketing category
ANDA
Marketing start
2010-12-22
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
71205-159-15Indomethacin15 in 1 BOTTLECAPSULE154
71205-159-20Indomethacin20 in 1 BOTTLECAPSULE204
71205-159-30Indomethacin30 in 1 BOTTLECAPSULE304
71205-159-60Indomethacin60 in 1 BOTTLECAPSULE604
71205-159-90Indomethacin90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-159-30EA - Each71205-159e8dfee1b-a1b9-479a-973a-287997f245df12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-159INDOMETHACIN CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 5 package rows20220825_b094eb04-3177-431d-b5ac-edc4804750a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSNb094eb04-3177-431d-b5ac-edc4804750a24
197818indomethacin 50 MG Oral CapsuleSCDb094eb04-3177-431d-b5ac-edc4804750a24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-159-157120501591515 CAPSULE in 1 BOTTLE (71205-159-15) 15 capsule2018-11-010000-00-00NoNoCurrent
71205-159-207120501592020 CAPSULE in 1 BOTTLE (71205-159-20) 20 capsule2018-11-010000-00-00NoNoCurrent
71205-159-307120501593030 CAPSULE in 1 BOTTLE (71205-159-30) 30 capsule2018-11-010000-00-00NoNoCurrent
71205-159-607120501596060 CAPSULE in 1 BOTTLE (71205-159-60) 60 capsule2018-11-010000-00-00NoNoCurrent
71205-159-907120501599090 CAPSULE in 1 BOTTLE (71205-159-90) 90 capsule2018-11-010000-00-00NoNoCurrent