FDA.reportPublic FDA data

INDOCIN

Product NDC
42211-101
11-digit product format
422110101
Labeler code
42211
Product ID
42211-101_cbb49cf2-5c9b-4c5c-8d5b-7efbfdde1355
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
indomethacin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Iroko Pharmaceuticals, LLC
Application
NDA018332
Marketing category
NDA
Marketing start
1985-10-10
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
25 mg/5mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42211-101-012020-01-31C16284748780-19d75b9d0-aa26-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use INDOCIN ® ORAL SUSPENSION safely and effectively. See full prescribing information for INDOCIN . INDOCIN ( indomethacin ) Oral Suspension , for oral use Initial U.S. Approval: 1965
42211-101-112020-01-31C16284748780-19d75b9d0-aa26-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use INDOCIN ® ORAL SUSPENSION safely and effectively. See full prescribing information for INDOCIN . INDOCIN ( indomethacin ) Oral Suspension , for oral use Initial U.S. Approval: 1965

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42211-101-01INDOCIN1 in 1 CARTONSUSPENSION111
42211-101-01INDOCIN50 mL in 1 BOTTLESUSPENSION5011
42211-101-11INDOCIN237 mL in 1 BOTTLESUSPENSION23711
42211-101-11INDOCIN1 in 1 CARTONSUSPENSION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42211-101-11ML - Milliliter42211-10199d472b3-b858-4ecd-bae6-2dd78de9023d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]9
INDOMETHACINACTIVE MOIETYXXE1CET956INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]9
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]9
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBINDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IINDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]9
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BINDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]9
SORBITOLINACTIVE INGREDIENT506T60A25RINDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]9
TRAGACANTHINACTIVE INGREDIENT2944357O2OINDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]9
WATERINACTIVE INGREDIENT059QF0KO0RINDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42211-101INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]11Legacy NDC, 4 package rows20180521_06de3c9d-63bf-47c1-f78c-4fbdd482928a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206971Indocin 25 MG in 5 mL Oral SuspensionPSN06de3c9d-63bf-47c1-f78c-4fbdd482928a11
310991indomethacin 25 MG in 5 mL Oral SuspensionPSN06de3c9d-63bf-47c1-f78c-4fbdd482928a11
206971indomethacin 5 MG/ML Oral Suspension [Indocin]SBD06de3c9d-63bf-47c1-f78c-4fbdd482928a11
310991indomethacin 5 MG/ML Oral SuspensionSCD06de3c9d-63bf-47c1-f78c-4fbdd482928a11
206971Indocin 25 MG per 5 ML Oral SuspensionSY06de3c9d-63bf-47c1-f78c-4fbdd482928a11
206971Indocin 5 MG/ML Oral SuspensionSY06de3c9d-63bf-47c1-f78c-4fbdd482928a11
310991indomethacin 25 MG per 5 ML Oral SuspensionSY06de3c9d-63bf-47c1-f78c-4fbdd482928a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42211-101-01422110101011 in 1 CARTONHistorical
42211-101-1142211010111237 mL in 1 BOTTLE237 mlHistorical