Home NDC 62135-022 Celecoxib
Product NDC 62135-022
11-digit product format 621350022
Labeler code 62135
Product ID 62135-022_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 200 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.
Product history page 1 of 4 · 148 observed 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 2026-02-19 14:30 UTC 2026-02 A211412-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211412-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211412-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211412-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211412-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211412-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211412-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211412-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211412-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211412-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211412-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211412-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211412-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211412-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211412-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211412-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211412-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211412-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211412-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211412-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211412-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211412-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211412-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211412-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211412-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211412-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211412-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211412-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211412-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211412-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211412-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211412-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211412-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211412-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211412-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211412-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211412-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211412-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211412-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211412-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-03-06 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Celecoxib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CELECOXIB 200 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 62135-022-01 Celecoxib 100 in 1 BOTTLE CAPSULE 100 6 62135-022-60 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 62135-022 CELECOXIB CAPSULE [CHARTWELL RX, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241016_a99a67f3-ccaa-4d54-8922-d6dd30fba274.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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): 62135-022
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 62135-022-01 62135002201 100 CAPSULE in 1 BOTTLE (62135-022-01) 100 capsule 2022-11-03 0000-00-00 No No Current 62135-022-60 62135002260 60 CAPSULE in 1 BOTTLE (62135-022-60) 60 capsule 2022-08-22 0000-00-00 No No Current