Indomethacin

Product NDC
62135-068
11-digit product format
621350068
Labeler code
62135
Product ID
62135-068_458c9652-de42-bf50-e063-6394a90a3325
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA070651
Marketing category
ANDA
Marketing start
1986-03-05
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
62135-068-18Indomethacin180 in 1 BOTTLECAPSULE1805
62135-068-90Indomethacin90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-068-18EA - Each62135-06852225fc4-aea8-4098-834c-eb0a0d61613612022-11-07
62135-068-90EA - Each62135-068bbf47c0f-4a81-4a8c-94b7-db9005a8a21112022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-068INDOMETHACIN CAPSULE [CHARTWELL RX, LLC]4Current NDC, Legacy NDC, 2 package rows20241226_d35bafd6-076d-4b94-bb0f-99be0addb505.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSNd35bafd6-076d-4b94-bb0f-99be0addb5055
197818indomethacin 50 MG Oral CapsuleSCDd35bafd6-076d-4b94-bb0f-99be0addb5055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-068-1862135006818180 CAPSULE in 1 BOTTLE (62135-068-18) 180 capsule2022-10-010000-00-00NoNoCurrent
62135-068-906213500689090 CAPSULE in 1 BOTTLE (62135-068-90) 90 capsule2022-10-010000-00-00NoNoCurrent