FDA.reportPublic FDA data

INDOMETHACIN

Product NDC
61919-130
11-digit product format
619190130
Labeler code
61919
Product ID
61919-130_4c48328a-3597-50f2-e063-6294a90af8ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INDOMETHACIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA091240
Marketing category
ANDA
Marketing start
2014-01-01
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
61919-130-152025-01-30C16284748780-19d75b9d0-4099-f424-e053-dadaa90a57ceINDOMETHACIN
61919-130-302025-01-30C16284748780-19d75b9d0-4099-f424-e053-dadaa90a57ceINDOMETHACIN
61919-130-602025-01-30C16284748780-12cef2736-a71a-d83d-e063-dadaa90ab31fINDOMETHACIN
61919-130-902025-01-30C16284748780-19d75b9d0-4099-f424-e053-dadaa90a57ceINDOMETHACIN
61919-130-152020-12-14C16284748780-19d75b9d0-4099-f424-e053-dadaa90a57ceINDOMETHACIN
61919-130-302020-12-14C16284748780-19d75b9d0-4099-f424-e053-dadaa90a57ceINDOMETHACIN
61919-130-902020-12-14C16284748780-19d75b9d0-4099-f424-e053-dadaa90a57ceINDOMETHACIN
61919-130-152020-01-31C16284748780-19d75b9d0-4099-f424-e053-dadaa90a57ceINDOMETHACIN
61919-130-302020-01-31C16284748780-19d75b9d0-4099-f424-e053-dadaa90a57ceINDOMETHACIN
61919-130-902020-01-31C16284748780-19d75b9d0-4099-f424-e053-dadaa90a57ceINDOMETHACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-130-15INDOMETHACIN15 in 1 BOTTLECAPSULE157
61919-130-21INDOMETHACIN21 in 1 BOTTLECAPSULE217
61919-130-30INDOMETHACIN30 in 1 BOTTLECAPSULE307
61919-130-90INDOMETHACIN90 in 1 BOTTLECAPSULE907
61919-130-60INDOMETHACIN60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-130-15EA - Each61919-130123f7c9e-cd67-442b-816a-cf6d807dcb3f12016-07-19
61919-130-60EA - Each61919-1308dd10479-8fca-49b9-9dd6-f266e6f0535b12019-09-05
61919-130-90EA - Each61919-130d3a69dda-6163-4dc9-955c-f2e3e4fc4bb612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [DIRECT RX]3
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [DIRECT RX]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [DIRECT RX]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [DIRECT RX]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [DIRECT RX]3
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [DIRECT RX]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [DIRECT RX]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [DIRECT RX]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-130INDOMETHACIN CAPSULE [DIRECT RX]6Current NDC, Legacy NDC, 4 package rows20230412_7e7175d7-5e43-4151-9702-88ac2cd44ef6.zip
61919-130INDOMETHACIN CAPSULE [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20200121_9131abdc-dd9c-22f1-e053-2a95a90ab011.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN7e7175d7-5e43-4151-9702-88ac2cd44ef67
197818indomethacin 50 MG Oral CapsuleSCD7e7175d7-5e43-4151-9702-88ac2cd44ef67
197818indomethacin 50 MG Oral CapsulePSN9131abdc-dd9c-22f1-e053-2a95a90ab0112
197818indomethacin 50 MG Oral CapsuleSCD9131abdc-dd9c-22f1-e053-2a95a90ab0112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-130-156191901301515 CAPSULE in 1 BOTTLE (61919-130-15) 15 capsule2014-01-010000-00-00NoNoCurrent
61919-130-216191901302121 CAPSULE in 1 BOTTLE (61919-130-21) 21 capsule2014-01-01NoNoHistorical
61919-130-306191901303030 CAPSULE in 1 BOTTLE (61919-130-30) 30 capsule2015-01-010000-00-00NoNoCurrent
61919-130-606191901306060 CAPSULE in 1 BOTTLE (61919-130-60) 60 capsule2019-08-280000-00-00NoNoCurrent
61919-130-906191901309090 CAPSULE in 1 BOTTLE (61919-130-90) 90 capsule2015-01-010000-00-00NoNoCurrent