Home NDC 64980-186 Griseofulvin
Product NDC 64980-186
11-digit product format 649800186
Labeler code 64980
Product ID 64980-186_7a7e6024-fcb1-4e9a-8de4-30d7c97210c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Griseofulvin
Dosage form TABLET
Route ORAL
Labeler Rising Pharmaceuticals Inc.
Application ANDA202482
Marketing category ANDA
Marketing start 2012-12-06
Marketing end 0000-00-00
Substance GRISEOFULVIN
Active strength 500 mg/1
Pharmacologic classes Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A202482-001 GRISEOFULVIN GRISEOFULVIN, MICROSIZE 500MG TABLET / ORAL AB 2012-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202482-001 AB
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 · 44 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 2026-10-15 13:18:30 2026-09 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A202482-001 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202482-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202482-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202482-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# 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 1 · 1 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 64980-186-01 64980018601 100 TABLET in 1 BOTTLE (64980-186-01) 100 tablet 2012-12-06 0000-00-00 No No Current 64980-186-03 64980018603 30 TABLET in 1 BOTTLE (64980-186-03) 30 tablet 2016-07-01 0000-00-00 No No Current