Home NDC 39822-0190-1 Acetazolamide
Product NDC 39822-0190
Requested package NDC 39822-0190-1
11-digit product format 398220190
Labeler code 39822
Product ID 39822-0190_36974f91-0025-447d-e063-6294a90a0dc2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetazolamide
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler XGen Pharmaceuticals DJB, Inc.
Application ANDA040784
Marketing category ANDA
Marketing start 2008-12-10
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 43 .
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 A040784-001 ACETAZOLAMIDE SODIUM ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040784-001 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.
Product history page 1 of 2 · 43 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 2026-09-14 22:38:34 2026-08 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 39822-0190-1 Acetazolamide 5 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 5 33 39822-0190-1 Acetazolamide 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 33
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAZOLAMIDE SODIUM ACTIVE INGREDIENT 429ZT169UH ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 22 ACETAZOLAMIDE ACTIVE MOIETY O3FX965V0I ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 22 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 22 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39822-0190 ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] 32 Current NDC, Legacy NDC, 2 package rows 20241004_a9199d3c-ce52-4db5-aa36-408f4e15e344.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 Marketing start Marketing end Sample Exclude flag Status 39822-0190-1 39822019001 1 VIAL, GLASS in 1 CARTON (39822-0190-1) / 5 mL in 1 VIAL, GLASS 2009-03-01 0000-00-00 No No Current