Home NDC 62135-021 Celecoxib
Product NDC 62135-021
11-digit product format 621350021
Labeler code 62135
Product ID 62135-021_459b4316-89e1-0bb1-e063-6294a90a518d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA211412
Marketing category ANDA
Marketing start 2020-03-06
Substance CELECOXIB
Active strength 100 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211412-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2020-03-06 A211412-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2020-03-06 A211412-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2020-03-06 A211412-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2020-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 A211412-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-03-06 a50c72e98297…2026-08-01 22:54:32 2026-06 A211412-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-03-06 a50c72e98297…2026-08-01 22:54:32 2026-06 A211412-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-03-06 a50c72e98297…2026-08-01 22:54:32 2026-06 A211412-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-03-06 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Celecoxib CELECOXIB Avet Pharmaceuticals Inc. 4bc96d0c-b484-3cee-e063-6294a90a9193 2026-03-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211412 application number: ANDA211412 Celecoxib CELECOXIB Yiling Pharmaceutical, Inc. 43979279-867b-4303-8f30-fc58ae75a069 2025-12-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211412 application number: ANDA211412 Celecoxib CELECOXIB Chartwell RX, LLC a99a67f3-ccaa-4d54-8922-d6dd30fba274 2025-12-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211412 application number: ANDA211412 ndc (product): 62135-021
Additional Listing Data#
Finished product Yes
Brand name base Celecoxib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CELECOXIB 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JCX84Q7J1L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205322 Internal RxNorm lookup 205323 Internal RxNorm lookup 349514 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 62135-021-60 Celecoxib 60 in 1 BOTTLE CAPSULE 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-021 CELECOXIB CAPSULE [CHARTWELL RX, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20241016_a99a67f3-ccaa-4d54-8922-d6dd30fba274.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 62135-021-60 62135002160 60 CAPSULE in 1 BOTTLE (62135-021-60) 60 capsule 2022-08-22 0000-00-00 No No Current