Home NDC 69367-449-01 Ibuprofen
Product NDC 69367-449
Requested package NDC 69367-449-01
11-digit product format 693670449
Labeler code 69367
Product ID 69367-449_a4e24f05-7843-49ee-be1a-28c1bef70523
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Westminster Pharmaceuticals, LLC
Application ANDA215318
Marketing category ANDA
Marketing start 2026-03-09
Substance IBUPROFEN
Active strength 800 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215318-001 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 A215318-002 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 A215318-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 3 · 96 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 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215318-002 IBUPROFEN 600MG TABLET / ORAL AB 2022-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215318-003 IBUPROFEN 800MG TABLET / ORAL AB 2022-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215318-001 IBUPROFEN 400MG TABLET / ORAL AB 2022-03-30 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 96 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 Ibuprofen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 800 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197805 Internal RxNorm lookup 197806 Internal RxNorm lookup 197807 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 69367-449-01 Ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 1 69367-449-05 Ibuprofen 500 in 1 BOTTLE TABLET, FILM COATED 500 1
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69367-449-01 69367044901 100 TABLET, FILM COATED in 1 BOTTLE (69367-449-01) 2026-03-09 No No Current