Home NDC 71921-180 Ibuprofen
Product NDC 71921-180
11-digit product format 719210180
Labeler code 71921
Product ID 71921-180_1f260910-03d9-fa2f-e063-6294a90ac0b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Florida Pharmaceutical Products, LLC
Application ANDA071268
Marketing category ANDA
Marketing start 2021-10-21
Substance IBUPROFEN
Active strength 400 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071268-001 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 A071268-002 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 A071268-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01
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 4 · 123 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 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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 Ibuprofen IBUPROFEN Major Pharmaceuticals 42b6faf5-ef47-6a7a-e063-6394a90ac409 2026-02-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071268 application number: ANDA071268 Ibuprofen IBUPROFEN NuCare Pharmaceuticals,Inc. f4d6372a-d560-0e14-e053-2a95a90a435a 2024-12-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071268 application number: ANDA071268 Ibuprofen IBUPROFEN Florida Pharmaceutical Products, LLC c1733fdb-5eed-2094-e053-2995a90a6c8e 2024-08-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071268 application number: ANDA071268 ndc (product): 71921-180
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 400 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 71921-180-01 Ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 5 71921-180-50 Ibuprofen 500 in 1 BOTTLE TABLET, FILM COATED 500 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71921-180 IBUPROFEN TABLET, FILM COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240809_c1733fdb-5eed-2094-e053-2995a90a6c8e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71921-180-01 71921018001 100 TABLET, FILM COATED in 1 BOTTLE (71921-180-01) 2021-10-21 0000-00-00 No No Current 71921-180-50 71921018050 500 TABLET, FILM COATED in 1 BOTTLE (71921-180-50) 2021-10-21 0000-00-00 No No Current