Home NDC 68083-661 Acetazolamide
Product NDC 68083-661
11-digit product format 680830661
Labeler code 68083
Product ID 68083-661_de1a5d68-b82d-4a84-9362-f7edd73f377a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetazolamide
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA219775
Marketing category ANDA
Marketing start 2025-06-17
Substance ACETAZOLAMIDE SODIUM
Active strength 500 mg/5mL
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 A219775-001 ACETAZOLAMIDE SODIUM ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2025-06-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219775-001 AP
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 A219775-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2025-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219775-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2025-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219775-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2025-06-17 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219775-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2025-06-17 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219775-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219775-001 AP 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219775-001 AP 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219775-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Acetazolamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAZOLAMIDE SODIUM 500 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 429ZT169UH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307702 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 68083-661-01 Acetazolamide 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 3 68083-661-01 Acetazolamide 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 3
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 68083-661-01 68083066101 1 VIAL in 1 CARTON (68083-661-01) / 5 mL in 1 VIAL 1 vial 2025-06-17 No No Current