Home NDC 42794-012-08 Griseofulvin
Product NDC 42794-012
Requested package NDC 42794-012-08
11-digit product format 427940012
Labeler code 42794
Product ID 42794-012_e8a91e6c-8bed-66f5-e053-2a95a90aa489
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Griseofulvin
Dosage form TABLET
Route ORAL
Labeler Sigmapharm Laboratories, LLC
Application ANDA202482
Marketing category ANDA
Marketing start 2012-12-06
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 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 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 · 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 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…2022-10-28 04:53 UTC 2022-10 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202482-001 GRISEOFULVIN 500MG TABLET / ORAL AB 2012-10-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Griseofulvin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GRISEOFULVIN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 32HRV3E3D5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310600 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 42794-012-08 Griseofulvin 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42794-012 GRISEOFULVIN TABLET [SIGMAPHARM LABORATORIES, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20220916_5bafb97f-621b-4b96-a787-68e0bb5c8637.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 1 · 1 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 42794-012-08 42794001208 30 TABLET in 1 BOTTLE (42794-012-08) 30 tablet 2016-07-01 0000-00-00 No No Current