Home NDC 62207-366 Ibuprofen
Product NDC 62207-366
11-digit product format 622070366
Labeler code 62207
Product ID 62207-366_1f8c5711-4342-d41b-e063-6394a90acb7a
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler Granules India Limited
Application ANDA079174
Marketing category ANDA
Marketing start 2011-01-01
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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 9 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 62207-366 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 62207-366 62207-366-24 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 62207-366 62207-366-25 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 62207-366 62207-366-26 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 62207-366 62207-366-27 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 62207-366 62207-366-66 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 62207-366 62207-366-67 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 62207-366 62207-366-68 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 62207-366 62207-366-80 UNFINISHED Active or certified unfinished drug listing 2026-10-05
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 4 · 189 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 A079174-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2010-12-10
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 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 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 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# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 DEXTROSE MONOHYDRATE INACTIVE INGREDIENT LX22YL083G IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 IBUPROFEN TABLET [GRANULES INDIA LIMITED] 11 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 DEXTROSE MONOHYDRATE INACTIVE INGREDIENT LX22YL083G IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 EGG PHOSPHOLIPIDS INACTIVE INGREDIENT 1Z74184RGV IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62207-366 IBUPROFEN TABLET [GRANULES INDIA LIMITED] 18 Current NDC, Legacy NDC, 8 package rows 20230131_fd01353d-1d1d-42b5-9a03-575052189bf5.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 3 of 4 · 70 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN AMERIFOODS TRADING COMPANY f6dc62db-f728-66fc-e053-6394a90a96b3 2025-07-15 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 IBUPROFEN IBUPROFEN AMERIFOODS TRADING COMPANY f6dc2a73-046b-6b93-e053-6294a90ab295 2025-07-15 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI 7b2f7a68-8f5e-a340-e053-2991aa0a5aeb 2025-07-01 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 IBUPROFEN IBUPROFEN AAA Pharmaceutical, Inc. 1e686091-6456-36c8-e063-6294a90a3866 2025-06-17 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN FSA STORE INC. ec6b015d-e72e-89c4-e053-2a95a90af81c 2025-06-17 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Marc Glassman, Inc. 47434f23-5ac9-4cb4-a963-7c8bf9e06361 2025-06-11 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Marc Glassman, Inc. 3b0e4ccc-cc0b-42fb-9163-7560740d9592 2025-06-11 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Redicare Ibuprofen 200mg IBUPROFEN 200MG Redicare LLC 2f0db953-33e2-1729-e063-6294a90af074 2025-03-04 Warnings, Adverse reactions Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Bi-Mart 7ceacd63-d5fa-4cab-b8f3-a5131c97bb90 2025-02-01 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN BI-MART 34440532-03e1-4feb-b3e2-dab869edeb15 2025-02-01 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen, Caseys 4good IBUPROFEN TABLETS Lil' Drug Store Products, Inc. 04b3ad8b-bdf9-47f3-e063-6294a90ac350 2024-12-31 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Spirit Pharmaceutical LLC 59c77fd3-5e67-45ec-82ad-44585390c4f3 2024-12-30 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Spirit Pharmaceutical LLC a96d012e-b132-4e99-b84b-ccd3a9a05cbb 2024-12-30 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Cabinet Pain Reliever and Fever Reducer IBUPROFEN Spirit Pharmaceutical LLC e172a8d8-779d-4ad9-b6b0-08a198a58034 2024-12-30 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Spirit Pharmaceutical LLC 9a93d4a8-07a1-4ac5-9bd9-5d5e4e62c2af 2024-12-20 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Dolgencorp, Inc. 5398f5b7-a9a6-4f7e-a06c-e524b9939562 2024-12-19 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Spirit Pharmaceuticals LLC e38d23e5-b455-41b5-86f6-c318b17bd345 2024-12-13 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Winco Foods, LLC 428b011f-d7d3-4a3b-87dd-d4e84e90cabd 2024-12-06 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Winco Foods, LLC 60130bdc-6f45-4998-b53a-cad6cbf25036 2024-12-06 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Granules India Limited fd01353d-1d1d-42b5-9a03-575052189bf5 2024-08-13 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 ndc (product): 62207-366
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 62207-366-24 62207036624 48000 TABLET in 1 BOX (62207-366-24) 48000 tablet 01-JAN-11 Current 62207-366-25 62207036625 71000 TABLET in 1 BOX (62207-366-25) 71000 tablet 01-JAN-11 Current 62207-366-26 62207036626 80000 TABLET in 1 BOX (62207-366-26) 80000 tablet 01-JAN-11 Current 62207-366-27 62207036627 97000 TABLET in 1 BOX (62207-366-27) 97000 tablet 01-JAN-11 Current 62207-366-41 62207036641 24 TABLET in 1 BOTTLE (62207-366-41) 24 tablet 2019-08-13 0000-00-00 No No Current 62207-366-42 62207036642 50 TABLET in 1 BOTTLE (62207-366-42) 50 tablet 2019-08-13 0000-00-00 No No Current 62207-366-43 62207036643 100 TABLET in 1 BOTTLE (62207-366-43) 100 tablet 2019-08-13 0000-00-00 No No Current 62207-366-46 62207036646 250 TABLET in 1 BOTTLE (62207-366-46) 250 tablet 2019-08-13 0000-00-00 No No Current 62207-366-47 62207036647 500 TABLET in 1 BOTTLE (62207-366-47) 500 tablet 2019-08-13 0000-00-00 No No Current 62207-366-48 62207036648 750 TABLET in 1 BOTTLE (62207-366-48) 750 tablet 2019-08-13 0000-00-00 No No Current 62207-366-49 62207036649 1000 TABLET in 1 BOTTLE (62207-366-49) 1000 tablet 2019-08-13 0000-00-00 No No Current 62207-366-51 62207036651 10 TABLET in 1 BOTTLE (62207-366-51) 10 tablet 2019-08-13 0000-00-00 No No Current 62207-366-66 62207036666 258000 TABLET in 1 DRUM (62207-366-66) 258000 tablet 01-JAN-11 Current 62207-366-67 62207036667 190476 TABLET in 1 DRUM (62207-366-67) 190476 tablet 01-JAN-11 Current 62207-366-68 62207036668 175000 TABLET in 1 BOX (62207-366-68) 175000 tablet 01-JAN-11 Current 62207-366-80 62207036680 258000 TABLET in 1 DRUM (62207-366-80) 258000 tablet 01-JAN-11 Current