Home NDC 49035-604-78 equate ibuprofen
Product NDC 49035-604
Requested package NDC 49035-604-78
11-digit product format 490350604
Labeler code 49035
Product ID 49035-604_74e7845e-9b6d-40ba-bb2c-b0a0178ea9c9
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wal-Mart Stores Inc
Application ANDA072096
Marketing category ANDA
Marketing start 1989-10-15
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
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 49035-604 49035-604-78 Y Unknown FDA exclusion code: Y excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 49035-604 49035-604-78 Y Unknown FDA exclusion code: Y excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 49035-604 49035-604-78 Y Unknown FDA exclusion code: Y excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A072096-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 1987-12-08
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 · 42 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 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base equate ibuprofen
Listing expiration 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49035-604-00 equate ibuprofen 500 in 1 BOTTLE TABLET, FILM COATED 500 12 49035-604-05 equate ibuprofen 2 in 1 PACKAGE TABLET, FILM COATED 2 12 49035-604-05 equate ibuprofen 500 in 1 BOTTLE TABLET, FILM COATED 500 12 49035-604-58 equate ibuprofen 40 in 1 BOTTLE TABLET, FILM COATED 40 12 49035-604-58 equate ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 12 49035-604-62 equate ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 12 49035-604-62 equate ibuprofen 24 in 1 BOTTLE TABLET, FILM COATED 24 12 49035-604-78 equate ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 12 49035-604-78 equate ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 12 49035-604-82 equate ibuprofen 2 in 1 CARTON TABLET, FILM COATED 2 12 49035-604-82 equate ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 12 49035-604-85 equate ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 12 49035-604-85 equate ibuprofen 250 in 1 BOTTLE TABLET, FILM COATED 250 12 49035-604-90 equate ibuprofen 2 in 1 PACKAGE TABLET, FILM COATED 2 12 49035-604-90 equate ibuprofen 250 in 1 BOTTLE TABLET, FILM COATED 250 12 49035-604-93 equate ibuprofen 1000 in 1 BOTTLE TABLET, FILM COATED 1000 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-604 EQUATE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 11 Current NDC, Legacy NDC, 16 package rows 20240726_b29034a6-657b-426f-a41a-5e64c4bc759d.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 4 · 67 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join IBUPROFEN IBUPROFEN Amazon.com Services LLC b5a47efe-222f-4cbd-b649-caafd16a0829 2026-07-29 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 ibuprofen IBUPROFEN HyVee Inc e7175dc9-db39-4452-a419-85af179de422 2026-07-16 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 good sense ibuprofen IBUPROFEN Bryant Ranch Prepack d6460cc3-c207-44e0-bf78-ad6fef055ed5 2026-07-09 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 ibuprofen IBUPROFEN Unit Dose Solutions, Inc. 551535ce-eab0-bb13-e063-6294a90a2070 2026-06-25 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 Berkley and Jensen Ibuprofen IBUPROFEN BJWC cda57e42-6106-46ee-82d1-479a692ee5bb 2026-05-21 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 good neighbor pharmacy ibuprofen IBUPROFEN Amerisource Bergen 085dcc1a-e4b0-4d08-9476-72275382d1a1 2026-05-15 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 good sense ibuprofen IBUPROFEN Preferred Pharmaceuticals Inc. f1a03b1f-2d87-43cc-b256-bd296ccd09f2 2026-05-13 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 ibuprofen IBUPROFEN Kroger Company 6307485a-8be6-40ee-899b-00eb3ee8ce61 2026-05-01 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 CounterAct IB IBUPROFEN Melaleuca, Inc 7fafc13e-3fee-ace3-e053-2a91aa0ac2ea 2026-03-17 Boxed warning, Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 Leader Ibuprofen IBUPROFEN Cardinal Health 110, LLC. dba Leader d673266c-3d2b-479f-9b53-cdd1b8651393 2026-02-25 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 ibuprofen IBUPROFEN HyVee Inc 4c24c884-55f7-40b4-8d6f-db6144d5ebcb 2026-02-05 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 ibuprofen IBUPROFEN HyVee Inc 5233c409-3743-4312-9f75-14ded6755b5c 2026-02-02 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 equate ibuprofen IBUPROFEN Wal-Mart Stores Inc b29034a6-657b-426f-a41a-5e64c4bc759d 2026-01-20 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 ndc (package): 49035-604-78 ndc (product): 49035-604 ndc11 (package): 49035060478 ibuprofen IBUPROFEN CVS Pharmacy ace493e6-91bc-41aa-8e5c-5bc14981de91 2026-01-06 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 ibuprofen IBUPROFEN Northwind Health Company, LLC da6c2802-5d15-dbcb-e053-2a95a90a2561 2026-01-01 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 good sense ibuprofen IBUPROFEN L. Perrigo Company 70d0a429-27c1-43a5-b2ea-a9919e0910f8 2025-12-22 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 ibuprofen IBUPROFEN NuCare Pharmaceuticals, Inc. 463ea713-6b27-b00b-e063-6394a90a8646 2025-12-18 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 ibuprofen IBUPROFEN PD-Rx Pharmaceuticals, Inc. 96bff700-bca3-4b94-b8a2-379102721db8 2025-12-15 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 good sense ibuprofen IBUPROFEN Preferred Pharmaceuticals Inc. c447fc6b-e9ef-447a-9609-5f893e18dfa7 2025-11-17 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096 GOODNOW PAIN RELIEF IBUPROFEN Gobrands, Inc 0759085d-6ac3-446b-ac2c-8dc30e32e1d1 2025-11-08 Warnings Exact identifier application applno (ANDA): 072096 application number: ANDA072096
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49035-604-78 49035060478 1 BOTTLE in 1 CARTON (49035-604-78) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1989-10-15 0000-00-00 No No Current