Home NDC 0781-5514 Griseofulvin
Product NDC 0781-5514
11-digit product format 007815514
Labeler code 0781
Product ID 0781-5514_79afc7a7-d77e-48eb-b1c6-6ea974801f38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Griseofulvin
Dosage form TABLET
Route ORAL
Labeler Sandoz Inc
Application ANDA091592
Marketing category ANDA
Marketing start 2013-08-07
Substance GRISEOFULVIN
Active strength 250 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091592-001 GRISEOFULVIN GRISEOFULVIN, MICROSIZE 250MG TABLET / ORAL AB 2013-08-07 A091592-002 GRISEOFULVIN GRISEOFULVIN, MICROSIZE 500MG TABLET / ORAL AB RS 2013-08-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL AB 2013-08-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL 2013-08-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL 2013-08-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL 2013-08-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL 2013-08-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL 2013-08-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091592-001 GRISEOFULVIN 250MG TABLET / ORAL 2013-08-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091592-002 GRISEOFULVIN 500MG TABLET / ORAL AB RS 2013-08-07 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 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 250 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 239239 Internal RxNorm lookup 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 0781-5514-01 Griseofulvin 100 in 1 BOTTLE TABLET 100 4 0781-5514-05 Griseofulvin 500 in 1 BOTTLE TABLET 500 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-5514 GRISEOFULVIN TABLET [SANDOZ INC] 3 Current NDC, Legacy NDC, 2 package rows 20191122_98829d90-b289-4bec-a625-7af412a5cb2d.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 0781-5514-01 00781551401 100 TABLET in 1 BOTTLE (0781-5514-01) 100 tablet 2013-08-07 0000-00-00 No No Current 0781-5514-05 00781551405 500 TABLET in 1 BOTTLE (0781-5514-05) 500 tablet 2013-08-07 0000-00-00 No No Current