FDA.reportPublic FDA data

Indomethacin

Product NDC
43063-368
11-digit product format
430630368
Labeler code
43063
Product ID
43063-368_508ccad6-eddc-ccfa-e063-6394a90a17cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA091276
Marketing category
ANDA
Marketing start
2010-12-22
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
43063-368-06Indomethacin6 in 1 BOTTLE, PLASTICCAPSULE618
43063-368-15Indomethacin15 in 1 BOTTLE, PLASTICCAPSULE1518
43063-368-30Indomethacin30 in 1 BOTTLE, PLASTICCAPSULE3018
43063-368-90Indomethacin90 in 1 BOTTLE, PLASTICCAPSULE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-368-06EA - Each43063-368817f84f6-3c81-4d08-ba70-d6dc5f23c63012012-07-24
43063-368-15EA - Each43063-36815aeade0-6e56-458d-bea5-909384ba1eab12017-06-15
43063-368-30EA - Each43063-3684b789460-6166-49e3-ba9b-4e23b12375eb12017-05-03
43063-368-90EA - Each43063-36866641a60-4bb4-4f19-985f-2dc4640d763212024-10-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOINDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TINDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-368INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 4 package rows20240922_b4cf01d1-0d71-4f0f-97a5-07a59744149f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSNb4cf01d1-0d71-4f0f-97a5-07a59744149f18
197817indomethacin 25 MG Oral CapsuleSCDb4cf01d1-0d71-4f0f-97a5-07a59744149f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-368-06430630368066 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-06) 6 capsule2012-02-230000-00-00NoNoCurrent
43063-368-154306303681515 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-15) 15 capsule2017-05-110000-00-00NoNoCurrent
43063-368-304306303683030 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-30) 30 capsule2017-02-070000-00-00NoNoCurrent
43063-368-904306303689090 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-90) 90 capsule2024-06-06NoNoHistorical