Home NDC 63868-979 Ibuprofen
Product NDC 63868-979
11-digit product format 638680979
Labeler code 63868
Product ID 63868-979_17c41cdc-d6d0-40cf-8ac3-ef7ba162b9ba
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CHAIN DRUG MARKETING ASSOCIATION INC
Application ANDA075010
Marketing category ANDA
Marketing start 1988-05-24
Marketing end 2028-02-28
Substance IBUPROFEN
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
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075010-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 1999-03-01
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 2 · 43 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 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 f41ea6bd6efb…
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 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310965 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 63868-979-10 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 17 63868-979-10 Ibuprofen 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 17 63868-979-24 Ibuprofen 24 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 24 17 63868-979-24 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 17 63868-979-50 Ibuprofen 50 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 50 17 63868-979-50 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 2 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-979 IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 15 Current NDC, Legacy NDC, 6 package rows 20250430_6521bc47-4d9c-4a5b-b109-3841f3be4b6c.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 2 of 3 · 48 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN L.N.K. International, Inc. d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c 2026-01-12 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN Meijer Distribution Inc c0c64ba5-b6b0-4221-9e44-110d92c93782 2026-01-12 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN DOLGENCORP, LLC 37ccb303-c70e-48b3-a8a3-2b0097cf8f88 2026-01-05 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN Northwind Health Company, LLC ab313564-27dc-0297-e053-2a95a90a6690 2026-01-01 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen 24/7 Life by 7-Eleven IBUPROFEN TABLET, FILM COATED Lil' Drug Store Products, Inc. 45b3b825-dab7-3328-e063-6294a90a7d2a 2025-12-11 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Physicians Care Ibuprofen IBUPROFEN 200MG Acme United Corporation 490c1109-dad7-4135-e054-00144ff8d46c 2025-10-31 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN CHAIN DRUG MARKETING ASSOCIATION INC 6521bc47-4d9c-4a5b-b109-3841f3be4b6c 2025-10-07 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 63868-979 Green Guard Ibupro relief IBUPROFEN Unifirst First Aid Corporation 2923c4a3-f994-67a7-e054-00144ff8d46c 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Medique Iprin IBUPROFEN Unifirst First Aid Corporation 2910b50b-c8de-382b-e054-00144ff88e88 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Medique at Home Iprin IBUPROFEN Unifirst First Aid Corporation b5547f33-2a81-867d-e053-2995a90aa2d0 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Direct Safety Ibuprofen IBUPROFEN Conney Safety Products, LLC 28d45743-d298-29db-e054-00144ff8d46c 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Unishield Ibuprofen IBUPROFEN Unishield b9e2e2ba-e2ad-eace-e053-2995a90aed35 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Uline Ibuprofen IBUPROFEN Uline d7342a15-9d49-74ed-e053-2a95a90a22cc 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Henry Schein Ibuprofen IBUPROFEN Henry Schein Inc. 267c7c8a-2f3f-1f4d-e054-00144ff8d46c 2025-09-08 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen Thompson IBUPROFEN Thompson Safety ccfbc048-f666-3188-e053-2995a90ae08f 2025-09-08 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN Sam's West Inc 6293a134-860d-4d12-9e4b-28490f824108 2025-09-03 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN Chain Drug Consortium 6c593a9c-680e-4645-8e8f-d8d044c92ca1 2025-07-18 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN Wildman Business Group 9e71f1c1-5272-4209-8974-6c525b141155 2024-08-19 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN NuCare Pharmaceuticals, Inc. 3e3848f2-4922-39ea-e054-00144ff88e88 2024-06-25 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 IBUPROFEN IBUPROFEN 200MG Lil' Drug Store Products, Inc. 8fc65767-1783-4f7f-8680-9e43ba4d5481 2024-06-19 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010
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 63868-979-10 63868097910 1 BOTTLE, PLASTIC in 1 CARTON (63868-979-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1988-05-24 2028-02-28 No No Current 63868-979-24 63868097924 1 BOTTLE, PLASTIC in 1 CARTON (63868-979-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1988-05-24 2028-02-28 No No Current 63868-979-50 63868097950 1 BOTTLE, PLASTIC in 1 CARTON (63868-979-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1988-05-24 2028-02-28 No No Current