Home NDC 0113-0604 good sense ibuprofen
Product NDC 0113-0604
11-digit product format 001130604
Labeler code 0113
Product ID 0113-0604_a8d7a45f-31d7-4bfc-a3ab-579552217154
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler L. Perrigo Company
Application ANDA072096
Marketing category ANDA
Marketing start 1989-09-15
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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
Additional Listing Data#
Finished product Yes
Brand name base good sense ibuprofen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0113-0604-02 good sense ibuprofen 550 in 1 BOTTLE TABLET, FILM COATED 550 11 0113-0604-52 good sense ibuprofen 10 in 1 VIAL TABLET, FILM COATED 10 11 0113-0604-62 good sense ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 11 0113-0604-62 good sense ibuprofen 24 in 1 BOTTLE TABLET, FILM COATED 24 11 0113-0604-71 good sense ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 11 0113-0604-71 good sense ibuprofen 50 in 1 BOTTLE TABLET, FILM COATED 50 11 0113-0604-76 good sense ibuprofen 120 in 1 BOTTLE TABLET, FILM COATED 120 11 0113-0604-76 good sense ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 11 0113-0604-78 good sense ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 11 0113-0604-78 good sense ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 11 0113-0604-82 good sense ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 11 0113-0604-82 good sense ibuprofen 2 in 1 CARTON TABLET, FILM COATED 2 11 0113-0604-85 good sense ibuprofen 250 in 1 BOTTLE TABLET, FILM COATED 250 11 0113-0604-90 good sense ibuprofen 500 in 1 BOTTLE TABLET, FILM COATED 500 11 0113-0604-93 good sense ibuprofen 1000 in 1 BOTTLE TABLET, FILM COATED 1000 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3 IBUPROFEN ACTIVE MOIETY WK2XYI10QM GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0113-0604 GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L. PERRIGO COMPANY] 10 Current NDC, Legacy NDC, 15 package rows 20250418_70d0a429-27c1-43a5-b2ea-a9919e0910f8.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.
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 0113-0604-02 00113060402 550 TABLET, FILM COATED in 1 BOTTLE (0113-0604-02) 2013-06-20 0000-00-00 No No Current 0113-0604-20 00113060420 1 BOTTLE in 1 CARTON (0113-0604-20) / 200 TABLET, FILM COATED in 1 BOTTLE (0113-0604-00) 1 bottle 2026-09-10 No No Current 0113-0604-52 00113060452 10 TABLET, FILM COATED in 1 VIAL (0113-0604-52) 1991-04-15 0000-00-00 No No Current 0113-0604-62 00113060462 1 BOTTLE in 1 CARTON (0113-0604-62) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1992-05-04 0000-00-00 No No Current 0113-0604-71 00113060471 1 BOTTLE in 1 CARTON (0113-0604-71) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1989-09-15 0000-00-00 No No Current 0113-0604-76 00113060476 1 BOTTLE in 1 CARTON (0113-0604-76) > 120 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1991-06-15 0000-00-00 No No Current 0113-0604-78 00113060478 1 BOTTLE in 1 CARTON (0113-0604-78) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1989-09-15 0000-00-00 No No Current 0113-0604-82 00113060482 2 BOTTLE in 1 CARTON (0113-0604-82) / 100 TABLET, FILM COATED in 1 BOTTLE 2 bottle 2011-03-02 0000-00-00 No No Current 0113-0604-85 00113060485 250 TABLET, FILM COATED in 1 BOTTLE (0113-0604-85) 2020-12-12 0000-00-00 No No Current 0113-0604-90 00113060490 500 TABLET, FILM COATED in 1 BOTTLE (0113-0604-90) 1993-01-18 0000-00-00 No No Current 0113-0604-93 00113060493 1000 TABLET, FILM COATED in 1 BOTTLE (0113-0604-93) 2007-05-31 0000-00-00 No No Current