Home NDC 62135-068 Indomethacin
Product NDC 62135-068
11-digit product format 621350068
Labeler code 62135
Product ID 62135-068_458c9652-de42-bf50-e063-6394a90a3325
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form CAPSULE
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA070651
Marketing category ANDA
Marketing start 1986-03-05
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070651-001 INDOMETHACIN INDOMETHACIN 50MG CAPSULE / ORAL AB 1986-03-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070651-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A070651-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1986-03-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A070651-001 AB 1 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base Indomethacin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INDOMETHACIN 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XXE1CET956 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197818 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-068-18 Indomethacin 180 in 1 BOTTLE CAPSULE 180 5 62135-068-90 Indomethacin 90 in 1 BOTTLE CAPSULE 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-068 INDOMETHACIN CAPSULE [CHARTWELL RX, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241226_d35bafd6-076d-4b94-bb0f-99be0addb505.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62135-068-18 62135006818 180 CAPSULE in 1 BOTTLE (62135-068-18) 180 capsule 2022-10-01 0000-00-00 No No Current 62135-068-90 62135006890 90 CAPSULE in 1 BOTTLE (62135-068-90) 90 capsule 2022-10-01 0000-00-00 No No Current