FDA.reportPublic FDA data

Indomethacin

Product NDC
51655-329
11-digit product format
516550329
Labeler code
51655
Product ID
51655-329_49d95913-f248-3972-e063-6294a90a9fb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA091276
Marketing category
ANDA
Marketing start
2020-11-20
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
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
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
51655-329-202026-01-29C16284748780-1f386c64a-07bd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965
51655-329-212026-01-29C16284748780-1f386c64a-07bd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965
51655-329-522026-01-29C16284748780-1f386c64a-07bd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965
51655-329-212023-03-23C16284748780-1f386c64a-07bd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965
51655-329-522023-03-23C16284748780-1f386c64a-07bd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965
51655-329-212023-01-30C16284748780-1f386c64a-07bd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965
51655-329-522023-01-30C16284748780-1f386c64a-07bd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-329-20Indomethacin20 in 1 BOTTLE, PLASTICCAPSULE204
51655-329-21Indomethacin21 in 1 BOTTLE, PLASTICCAPSULE214
51655-329-52Indomethacin30 in 1 BOTTLE, PLASTICCAPSULE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-329INDOMETHACIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 3 package rows20241219_c9f4eda2-5c8f-72eb-e053-2a95a90a06be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSNc9f4eda2-5c8f-72eb-e053-2a95a90a06be4
197818indomethacin 50 MG Oral CapsuleSCDc9f4eda2-5c8f-72eb-e053-2a95a90a06be4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-329-205165503292020 CAPSULE in 1 BOTTLE, PLASTIC (51655-329-20) 20 capsule2023-01-08NoNoCurrent
51655-329-215165503292121 CAPSULE in 1 BOTTLE, PLASTIC (51655-329-21) 21 capsule2020-11-200000-00-00NoNoCurrent
51655-329-525165503295230 CAPSULE in 1 BOTTLE, PLASTIC (51655-329-52) 30 capsule2021-01-140000-00-00NoNoCurrent