Home NDC 68094-808 Methazolamide
Product NDC 68094-808
11-digit product format 680940808
Labeler code 68094
Product ID 68094-808_5dc8c6ca-5710-4369-b0ae-37666210f03b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methazolamide
Dosage form TABLET
Route ORAL
Labeler Precision Dose, Inc.
Application ANDA215615
Marketing category ANDA
Marketing start 2023-11-30
Substance METHAZOLAMIDE
Active strength 50 mg/1
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 A215615-001 METHAZOLAMIDE METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 A215615-002 METHAZOLAMIDE METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18
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 2 · 50 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 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215615-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2022-10-18 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215615-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2022-10-18 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methazolamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHAZOLAMIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W733B0S9SD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197939 Internal RxNorm lookup 197940 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 68094-808-50 Methazolamide 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68094-808 METHAZOLAMIDE TABLET [PRECISION DOSE, INC.] 1 Current NDC, 1 package rows 20231205_1e0e81c7-a328-4034-a6b3-4c83e9ac3a3e.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 Sample Exclude flag Status 68094-808-50 68094080850 100 TABLET in 1 BOTTLE (68094-808-50) 100 tablet 2023-11-30 No No Current