FDA.reportPublic FDA data

Indomethacin

Product NDC
43063-773
11-digit product format
430630773
Labeler code
43063
Product ID
43063-773_5259da00-b583-eff5-e063-6294a90a28b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA091240
Marketing category
ANDA
Marketing start
2016-05-19
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
43063-773-15Indomethacin15 in 1 BOTTLE, PLASTICCAPSULE1514
43063-773-30Indomethacin30 in 1 BOTTLE, PLASTICCAPSULE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-773-15EA - Each43063-7732c99b508-954b-4635-8414-b2d7a73c8b0912017-09-11
43063-773-30EA - Each43063-773f9452850-007b-48dd-94ce-dbf5c95b2eea12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-773INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 2 package rows20250309_ce866d3a-7bea-4d82-9b7d-79e8a294c141.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSNce866d3a-7bea-4d82-9b7d-79e8a294c14114
197817indomethacin 25 MG Oral CapsuleSCDce866d3a-7bea-4d82-9b7d-79e8a294c14114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-773-154306307731515 CAPSULE in 1 BOTTLE, PLASTIC (43063-773-15) 15 capsule2017-08-030000-00-00NoNoCurrent
43063-773-304306307733030 CAPSULE in 1 BOTTLE, PLASTIC (43063-773-30) 30 capsule2017-06-220000-00-00NoNoCurrent