Home NDC 0615-8572 Celecoxib
Product NDC 0615-8572
11-digit product format 006158572
Labeler code 0615
Product ID 0615-8572_96cd538d-9ca7-4c69-8054-c27c3ed39262
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA206827
Marketing category ANDA
Marketing start 2016-02-01
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 42 .
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 A206827-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 A206827-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 A206827-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 A206827-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01
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 5 · 168 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 2026-08-18 06:07:40 2026-07 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205322 Internal RxNorm lookup 205323 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 0615-8572-39 Celecoxib 30 in 1 BLISTER PACK CAPSULE 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0615-8572 CELECOXIB CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] 1 Current NDC, 1 package rows 20250223_34bef49c-eca1-4f17-9b1b-55900ac40829.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0615-8572-39 00615857239 30 CAPSULE in 1 BLISTER PACK (0615-8572-39) 30 capsule 2025-02-11 No No Current