FDA.reportPublic FDA data

Indomethacin

Product NDC
66267-120
11-digit product format
662670120
Labeler code
66267
Product ID
66267-120_1f93ab41-21da-bcb5-e063-6294a90a4c36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA091240
Marketing category
ANDA
Marketing start
2011-11-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-120-202024-08-13C16284748780-1f386c649-c258-0266-e053-dadaa90a7c1aIndomethacin Capsule, USP Rx only
66267-120-302024-08-13C16284748780-1f386c649-c258-0266-e053-dadaa90a7c1aIndomethacin Capsule, USP Rx only
66267-120-202023-01-30C16284748780-1f386c649-c258-0266-e053-dadaa90a7c1aIndomethacin Capsule, USP Rx only
66267-120-302023-01-30C16284748780-1f386c649-c258-0266-e053-dadaa90a7c1aIndomethacin Capsule, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-120-20Indomethacin20 in 1 BOTTLECAPSULE205
66267-120-30Indomethacin30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-120-20EA - Each66267-120474190aa-f774-4cec-821e-7670d0709df712016-11-08
66267-120-30EA - Each66267-12012de9845-f901-4966-9e68-2c099a3403e912016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-120INDOMETHACIN CAPSULE [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20240815_3e87e34a-6556-4b0f-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN3e87e34a-6556-4b0f-e054-00144ff8d46c5
197818indomethacin 50 MG Oral CapsuleSCD3e87e34a-6556-4b0f-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-120-206626701202020 CAPSULE in 1 BOTTLE (66267-120-20) 20 capsule2016-10-100000-00-00NoNoCurrent
66267-120-306626701203030 CAPSULE in 1 BOTTLE (66267-120-30) 30 capsule2016-10-100000-00-00NoNoCurrent