Indomethacin

Product NDC
70710-1852
11-digit product format
707101852
Labeler code
70710
Product ID
70710-1852_796d8f36-e2ba-4f03-8e37-28590adfaed0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA216184
Marketing category
ANDA
Marketing start
2023-08-03
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
Rxcui197819

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
70710-1852-6Indomethacin6 in 1 BLISTER PACKSUPPOSITORY64
70710-1852-7Indomethacin5 in 1 CARTONSUPPOSITORY54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1852-6EA - Each70710-1852f4f6300c-78d3-4e15-a445-35c7aa1d2d9f12023-09-05
70710-1852-7EA - Each70710-18528a356112-7f8f-49f4-bdaf-7c66efe0a35b12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1852INDOMETHACIN SUPPOSITORY [ZYDUS PHARMACEUTICALS USA INC.]4Current NDC, 2 package rows20241009_595e2f3e-c6d4-4a17-bc06-46512b4275b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197819indomethacin 50 MG Rectal SuppositoryPSN595e2f3e-c6d4-4a17-bc06-46512b4275b54
197819indomethacin 50 MG Rectal SuppositorySCD595e2f3e-c6d4-4a17-bc06-46512b4275b54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1852-6707101852066 in 1 BLISTER PACKHistorical
70710-1852-7707101852075 BLISTER PACK in 1 CARTON (70710-1852-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1852-6) 5 blister pack2023-08-03NoNoCurrent