FDA.reportPublic FDA data

INDOMETHACIN

Product NDC
62135-067
11-digit product format
621350067
Labeler code
62135
Product ID
62135-067_3143c8a1-9d17-9eb6-e063-6394a90ab16b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INDOMETHACIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
NDA018829
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1984-08-06
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018829-001INDOMETHACININDOMETHACIN50MGCAPSULE / ORALAB1984-08-06
N018829-002INDOMETHACININDOMETHACIN25MGCAPSULE / ORALAB1984-08-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N018829-001AB
N018829-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N018829-001INDOMETHACIN50MGCAPSULE / ORALAB1984-08-06a50c72e98297…
2026-08-01 22:54:322026-06N018829-002INDOMETHACIN25MGCAPSULE / ORALAB1984-08-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N018829-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N018829-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INDOMETHACININDOMETHACINChartwell RX, LLC9607920c-4d25-40b9-957e-87e9ca5574e82025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018829
application number: NDA018829
ndc (product): 62135-067

Additional Listing Data#

Finished product
Yes
Brand name base
INDOMETHACIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDOMETHACIN25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XXE1CET956Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197817Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9607920c-4d25-40b9-957e-87e9ca5574e8Available on FDA.report

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
62135-067-18INDOMETHACIN180 in 1 BOTTLECAPSULE1804
62135-067-90INDOMETHACIN90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-067-18EA - Each62135-067a938eff9-a546-4d5e-af62-ecf106bfda2412022-11-07
62135-067-90EA - Each62135-0672695b055-0af7-41ba-8516-2cb4673f834812022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-067INDOMETHACIN CAPSULE [CHARTWELL RX, LLC]4Current NDC, Legacy NDC, 2 package rows20250328_9607920c-4d25-40b9-957e-87e9ca5574e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN9607920c-4d25-40b9-957e-87e9ca5574e84
197817indomethacin 25 MG Oral CapsuleSCD9607920c-4d25-40b9-957e-87e9ca5574e84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-067-1862135006718180 CAPSULE in 1 BOTTLE (62135-067-18) 180 capsule2022-09-300000-00-00NoNoCurrent
62135-067-906213500679090 CAPSULE in 1 BOTTLE (62135-067-90) 90 capsule2022-09-300000-00-00NoNoCurrent