Home NDC 70709-085 ORMALVI
Product NDC 70709-085
11-digit product format 707090085
Labeler code 70709
Product ID 70709-085_8716de8d-f4b6-4192-892c-cb22b511257c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dichlorphenamide
Dosage form TABLET
Route ORAL
Labeler Cycle Pharmaceuticals Ltd.
Application ANDA215924
Marketing category ANDA
Marketing start 2024-03-15
Substance DICHLORPHENAMIDE
Active strength 50 mg/1
Pharmacologic classes Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
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 A215924-001 ORMALVI DICHLORPHENAMIDE 50MG TABLET / ORAL AB 2022-12-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215924-001 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.
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 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215924-001 DICHLORPHENAMIDE 50MG TABLET / ORAL AB 2022-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215924-001 DICHLORPHENAMIDE 50MG TABLET / ORAL AB 2022-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215924-001 DICHLORPHENAMIDE 50MG TABLET / ORAL AB 2022-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215924-001 DICHLORPHENAMIDE 50MG TABLET / ORAL AB 2022-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215924-001 DICHLORPHENAMIDE 50MG TABLET / ORAL AB 2022-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215924-001 DICHLORPHENAMIDE 50MG TABLET / ORAL AB 2022-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215924-001 DICHLORPHENAMIDE 50MG TABLET / ORAL AB 2022-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215924-001 DICHLORPHENAMIDE 50MG TABLET / ORAL AB 2022-12-29 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215924-001 ORMALVI 50MG TABLET / ORAL AB 2022-12-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ORMALVI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICHLORPHENAMIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VVJ6673MHY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197594 Internal RxNorm lookup 2677447 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 70709-085-10 ORMALVI 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70709-085 ORMALVI (DICHLORPHENAMIDE) TABLET [CYCLE PHARMACEUTICALS LTD.] 1 Current NDC, 1 package rows 20240316_3989e220-6502-449b-be39-e2689acce08c.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 · 2 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 70709-085-10 70709008510 100 TABLET in 1 BOTTLE (70709-085-10) 100 tablet 2024-03-15 No No Current