Home NDC 73308-435 ULTRAMICROSIZE GRISEOFULVIN
Product NDC 73308-435
11-digit product format 733080435
Labeler code 73308
Product ID 73308-435_2d3fc650-5035-982f-e063-6394a90a6fd4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ULTRAMICROSIZE GRISEOFULVIN
Dosage form TABLET
Route ORAL
Labeler Ayurax, LLC.
Application ANDA061996
Marketing category ANDA
Marketing start 1982-04-06
Substance GRISEOFULVIN
Active strength 165 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A061996-001 FULVICIN P/G GRISEOFULVIN, ULTRAMICROSIZE 125MG TABLET / ORAL AB Approved before 1982 A061996-002 FULVICIN P/G GRISEOFULVIN, ULTRAMICROSIZE 250MG TABLET / ORAL AB Approved before 1982 A061996-003 FULVICIN P/G 165 GRISEOFULVIN, ULTRAMICROSIZE 165MG TABLET / ORAL 1982-04-06 A061996-004 FULVICIN P/G 330 GRISEOFULVIN, ULTRAMICROSIZE 330MG TABLET / ORAL 1982-04-06
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 5 · 164 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 A061996-001 FULVICIN P/G 125MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061996-002 FULVICIN P/G 250MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061996-003 FULVICIN P/G 165 165MG TABLET / ORAL 1982-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061996-004 FULVICIN P/G 330 330MG TABLET / ORAL 1982-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061996-001 FULVICIN P/G 125MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061996-002 FULVICIN P/G 250MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061996-003 FULVICIN P/G 165 165MG TABLET / ORAL 1982-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061996-004 FULVICIN P/G 330 330MG TABLET / ORAL 1982-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A061996-001 FULVICIN P/G 125MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061996-002 FULVICIN P/G 250MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061996-003 FULVICIN P/G 165 165MG TABLET / ORAL 1982-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061996-004 FULVICIN P/G 330 330MG TABLET / ORAL 1982-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061996-001 FULVICIN P/G 125MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061996-002 FULVICIN P/G 250MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061996-003 FULVICIN P/G 165 165MG TABLET / ORAL 1982-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061996-004 FULVICIN P/G 330 330MG TABLET / ORAL 1982-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061996-001 FULVICIN P/G 125MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061996-002 FULVICIN P/G 250MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061996-003 FULVICIN P/G 165 165MG TABLET / ORAL 1982-04-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061996-004 FULVICIN P/G 330 330MG TABLET / ORAL 1982-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061996-001 FULVICIN P/G 125MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061996-002 FULVICIN P/G 250MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061996-003 FULVICIN P/G 165 165MG TABLET / ORAL 1982-04-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061996-004 FULVICIN P/G 330 330MG TABLET / ORAL 1982-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061996-001 FULVICIN P/G 125MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061996-002 FULVICIN P/G 250MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061996-003 FULVICIN P/G 165 165MG TABLET / ORAL 1982-04-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061996-004 FULVICIN P/G 330 330MG TABLET / ORAL 1982-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061996-001 FULVICIN P/G 125MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061996-002 FULVICIN P/G 250MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061996-003 FULVICIN P/G 165 165MG TABLET / ORAL 1982-04-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061996-004 FULVICIN P/G 330 330MG TABLET / ORAL 1982-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061996-001 FULVICIN P/G 125MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061996-002 FULVICIN P/G 250MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061996-003 FULVICIN P/G 165 165MG TABLET / ORAL 1982-04-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061996-004 FULVICIN P/G 330 330MG TABLET / ORAL 1982-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A061996-001 FULVICIN P/G 125MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A061996-002 FULVICIN P/G 250MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A061996-003 FULVICIN P/G 165 165MG TABLET / ORAL 1982-04-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A061996-004 FULVICIN P/G 330 330MG TABLET / ORAL 1982-04-06 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ULTRAMICROSIZE GRISEOFULVIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GRISEOFULVIN 165 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 245248 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 73308-435-30 ULTRAMICROSIZE GRISEOFULVIN 30 in 1 BOTTLE TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73308-435 ULTRAMICROSIZE GRISEOFULVIN TABLET [AYURAX, LLC.] 1 Current NDC, 1 package rows 20250205_43fc5201-d23c-4d83-9247-baefe03774ef.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73308-435-30 73308043530 30 TABLET in 1 BOTTLE (73308-435-30) 30 tablet 2025-01-30 No No Current