Home NDC 49035-521 equate ibuprofen
Product NDC 49035-521
11-digit product format 490350521
Labeler code 49035
Product ID 49035-521_e1ed3aec-11a3-4ef5-8631-4ef8ccb7a061
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Wal-Mart Stores Inc
Application ANDA076359
Marketing category ANDA
Marketing start 2011-10-25
Substance IBUPROFEN
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 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076359-001 IBUPROFEN IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 A076359-002 IBUPROFEN IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16
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 · 82 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 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base equate ibuprofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 100 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 310963 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 49035-521-62 equate ibuprofen 24 in 1 BOTTLE TABLET, CHEWABLE 24 7 49035-521-62 equate ibuprofen 1 in 1 CARTON TABLET, CHEWABLE 1 7 49035-521-67 equate ibuprofen 2 in 1 CARTON TABLET, CHEWABLE 2 7 49035-521-67 equate ibuprofen 24 in 1 BOTTLE TABLET, CHEWABLE 24 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3 IBUPROFEN ACTIVE MOIETY WK2XYI10QM EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3 SUCCINIC ACID INACTIVE INGREDIENT AB6MNQ6J6L EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-521 EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC] 6 Current NDC, Legacy NDC, 4 package rows 20221014_abef43bc-ee9b-4a9c-9cf9-36c323213909.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 2 · 36 matching rows.
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 49035-521-62 49035052162 1 BOTTLE in 1 CARTON (49035-521-62) / 24 TABLET, CHEWABLE in 1 BOTTLE 1 bottle 2011-10-25 0000-00-00 No No Current 49035-521-67 49035052167 2 BOTTLE in 1 CARTON (49035-521-67) / 24 TABLET, CHEWABLE in 1 BOTTLE 2 bottle 2011-10-25 0000-00-00 No No Current