Home NDC 21130-877 signature care ibuprofen
Product NDC 21130-877
11-digit product format 211300877
Labeler code 21130
Product ID 21130-877_87316e1c-bbd4-4a09-ae05-2a4a6cb5f3ef
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Safeway
Application ANDA077349
Marketing category ANDA
Marketing start 2015-09-14
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077349-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21
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 · 41 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 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base signature care ibuprofen
Listing expiration 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21130-877-78 signature care ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 4 21130-877-78 signature care ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 4
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] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21130-877 SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 4 Current NDC, Legacy NDC, 2 package rows 20240206_95904b21-752d-48b4-a882-8d81d2384e1f.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 · 21 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 21130-877-78 21130087778 1 BOTTLE in 1 CARTON (21130-877-78) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2015-09-14 0000-00-00 No No Current