Indomethacin

Product NDC
21695-523
11-digit product format
216950523
Labeler code
21695
Product ID
21695-523_4755e174-f5d7-451a-9649-46222a6dfced
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA070756
Marketing category
ANDA
Marketing start
1986-02-12
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
50 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-523-15Indomethacin15 in 1 BOTTLECAPSULE151
21695-523-21Indomethacin21 in 1 BOTTLECAPSULE211
21695-523-30Indomethacin30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-523-15EA - Each21695-523befbcea1-bf56-44a2-9eac-e5c2e6a457f612012-07-24
21695-523-21EA - Each21695-5232513ef89-052e-4983-af8b-fb8b8544931a12012-07-24
21695-523-30EA - Each21695-5238c36479c-9ea8-454b-94dc-272e8451af0712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IndomethacinACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
IndomethacinACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-523INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20101119_4755e174-f5d7-451a-9649-46222a6dfced.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN4755e174-f5d7-451a-9649-46222a6dfced1
197818indomethacin 50 MG Oral CapsuleSCD4755e174-f5d7-451a-9649-46222a6dfced1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-523-152169505231515 in 1 BOTTLEHistorical
21695-523-212169505232121 in 1 BOTTLEHistorical
21695-523-302169505233030 in 1 BOTTLEHistorical