Home NDC 69097-361 grisofulvin
Product NDC 69097-361
11-digit product format 690970361
Labeler code 69097
Product ID 69097-361_6cf78fd3-5be6-412c-acdf-f599efaf0654
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name grisofulvin
Dosage form SUSPENSION
Route ORAL
Labeler Cipla USA Inc.
Application ANDA065354
Marketing category ANDA
Marketing start 2017-03-06
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 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 A065354-001 GRISEOFULVIN GRISEOFULVIN, MICROSIZE 125MG/5ML SUSPENSION / ORAL AB 2007-09-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065354-001 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 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065354-001 GRISEOFULVIN 125MG/5ML SUSPENSION / ORAL AB 2007-09-10 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 grisofulvin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GRISEOFULVIN 125 mg/5mL
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 239238 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 69097-361-08 grisofulvin 120 mL in 1 BOTTLE SUSPENSION 120 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-361 GRISOFULVIN SUSPENSION [CIPLA USA INC.] 6 Current NDC, Legacy NDC, 1 package rows 20240328_d5c737e5-51b8-4322-a2a5-4d4a392c1f56.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 69097-361-08 69097036108 120 mL in 1 BOTTLE (69097-361-08) 120 ml 2017-03-06 0000-00-00 No No Current