Home NDC 62207-365-16 Ibuprofen
Product NDC 62207-365
Requested package NDC 62207-365-16
11-digit product format 622070365
Labeler code 62207
Product ID 62207-365_f37b04a6-8c5f-0644-e053-2995a90a40a0
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 20 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 62207-365 62207-365-16 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 263afe128892…91768de4ddbe…
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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 cb3db0bc1861…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 4 · 69 matching rows.
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62207-365 IBUPROFEN TABLET [GRANULES INDIA LIMITED] 18 Current NDC, Legacy NDC, 8 package rows 20230131_fd01353d-1d1d-42b5-9a03-575052189bf5.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 62207-365-16 62207036516 258899 TABLET in 1 DRUM (62207-365-16) 258899 tablet 10-NOV-19 Current