Home NDC 21130-585 Signature Care Ibuprofen
Product NDC 21130-585
11-digit product format 211300585
Labeler code 21130
Product ID 21130-585_e7c23152-612b-4733-bb76-09a6929eddba
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Safeway
Application ANDA072096
Marketing category ANDA
Marketing start 2015-08-12
Marketing end 0000-00-00
Substance IBUPROFEN
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 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 · 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 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2 IBUPROFEN ACTIVE MOIETY WK2XYI10QM SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21130-585 SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 7 Legacy NDC 20200130_bc258e91-2750-4c4e-bcbf-6c96f0d41f54.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 4 · 62 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 21130-585-59 21130058559 750 TABLET, FILM COATED in 1 BOTTLE (21130-585-59) 2015-11-13 0000-00-00 No No Current 21130-585-62 21130058562 1 BOTTLE in 1 CARTON (21130-585-62) > 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2015-09-04 0000-00-00 No No Current 21130-585-76 21130058576 1 BOTTLE in 1 CARTON (21130-585-76) > 120 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2017-06-27 0000-00-00 No No Current 21130-585-78 21130058578 1 BOTTLE in 1 CARTON (21130-585-78) > 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2015-09-04 0000-00-00 No No Current 21130-585-85 21130058585 250 TABLET, FILM COATED in 1 BOTTLE (21130-585-85) 2015-09-01 0000-00-00 No No Current 21130-585-90 21130058590 500 TABLET, FILM COATED in 1 BOTTLE (21130-585-90) 2015-08-12 0000-00-00 No No Current 21130-585-93 21130058593 1000 TABLET, FILM COATED in 1 BOTTLE (21130-585-93) 2018-07-11 0000-00-00 No No Current