Home NDC 80432-056 Griseofulvin Oral Suspension
Product NDC 80432-056
11-digit product format 804320056
Labeler code 80432
Product ID 80432-056_f1ea506d-0062-7849-e053-2995a90a94ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Griseofulvin Oral Suspension
Dosage form SUSPENSION
Route ORAL
Labeler TriRx Huntsville Pharmaceutical Services LLC
Application ANDA065438
Marketing category ANDA
Marketing start 2022-08-09
Marketing end 0000-00-00
Substance GRISEOFULVIN
Active strength 125 mg/5mL
Pharmacologic classes Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]
NDC exclude flag No
Listing certified through 2024-12-31
Current FDA listing Historical FDA.report record 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 A065438-001 GRISEOFULVIN GRISEOFULVIN, MICROSIZE 125MG/5ML SUSPENSION / ORAL AB 2010-10-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065438-001 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 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065438-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2010-10-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 80432-056-11 80432005611 118 mL in 1 BOTTLE (80432-056-11) 118 ml 2022-08-09 0000-00-00 No No Current