Indomethacin

Product NDC
51655-963
11-digit product format
516550963
Labeler code
51655
Product ID
51655-963_4bc16525-0f06-876a-e063-6294a90aa04a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA091240
Marketing category
ANDA
Marketing start
2022-05-04
Substance
INDOMETHACIN
Active strength
25 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
INDOMETHACIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXXE1CET956
Rxcui197817

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
51655-963-52Indomethacin30 in 1 BOTTLE, PLASTICCAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-963INDOMETHACIN CAPSULE [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 1 package rows20231219_dffe9b95-3cb6-4c4e-e053-2a95a90a9328.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSNdffe9b95-3cb6-4c4e-e053-2a95a90a93285
197817indomethacin 25 MG Oral CapsuleSCDdffe9b95-3cb6-4c4e-e053-2a95a90a93285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-963-525165509635230 CAPSULE in 1 BOTTLE, PLASTIC (51655-963-52) 30 capsule2022-05-040000-00-00NoNoCurrent