Home NDC 70518-4009 Celecoxib
Product NDC 70518-4009
11-digit product format 705184009
Labeler code 70518
Product ID 70518-4009_51254983-b0b4-6424-e063-6394a90a4758
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA208701
Marketing category ANDA
Marketing start 2024-02-05
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A208701-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 A208701-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 A208701-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 A208701-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14
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 · 160 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 2026-09-14 22:38:34 2026-08 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Celecoxib
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205322 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 70518-4009-0 Celecoxib 100 in 1 BOX CAPSULE 100 4 70518-4009-1 Celecoxib 1 in 1 POUCH CAPSULE 1 4 70518-4009-2 Celecoxib 100 in 1 BOX CAPSULE 100 4 70518-4009-3 Celecoxib 1 in 1 POUCH CAPSULE 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4009 CELECOXIB CAPSULE [REMEDYREPACK INC.] 1 Current NDC, 4 package rows 20240207_56d64558-1fad-420e-8fcd-7103cd073127.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Celecoxib CELECOXIB REMEDYREPACK INC. 56d64558-1fad-420e-8fcd-7103cd073127 2026-05-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208701 application number: ANDA208701 ndc (product): 70518-4009 Celecoxib CELECOXIB Modavar Pharmaceuticals LLC b0f73074-f3d8-4812-8e64-f88a02869ed3 2024-12-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208701 application number: ANDA208701 Celecoxib CELECOXIB Cadila Pharmaceuticals Limited 78ce3df5-07ee-43bb-9348-104a9524a032 2024-12-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208701 application number: ANDA208701 Celecoxib CELECOXIB Bryant Ranch Prepack 1bf407db-8bc6-4aea-8bcc-eaa4c24cb7a6 2024-11-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208701 application number: ANDA208701
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4009-0 70518400900 100 POUCH in 1 BOX (70518-4009-0) / 1 CAPSULE in 1 POUCH (70518-4009-1) 100 pouch 2024-02-05 No No Current 70518-4009-1 70518400901 1 in 1 POUCH Historical 70518-4009-2 70518400902 100 POUCH in 1 BOX (70518-4009-2) / 1 CAPSULE in 1 POUCH (70518-4009-3) 100 pouch 2026-05-05 No No Current 70518-4009-3 70518400903 1 in 1 POUCH Historical