Acetazolamide

Product NDC
23155-831
11-digit product format
231550831
Labeler code
23155
Product ID
23155-831_c4181e7e-fe5c-47ea-b442-a115eee18238
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA202693
Marketing category
ANDA
Marketing start
2022-11-15
Marketing end
2027-09-30
Substance
ACETAZOLAMIDE SODIUM
Active strength
500 mg/5mL
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
NDC exclude flag
No
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202693-001ACETAZOLAMIDE SODIUMACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202693-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2014-12-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2014-12-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2014-12-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2014-12-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2014-12-193f01610625f2…
2019-09-15 20:21 UTC2019-09A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202693-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-12-19cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202693-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202693-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202693-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202693-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202693-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202693-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202693-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202693-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202693-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202693-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202693-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202693-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202693-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202693-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202693-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202693-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202693-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202693-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202693-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202693-001AP1782e0a99824c…
2019-09-15 20:21 UTC2019-09A202693-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202693-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202693-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202693-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202693-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202693-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202693-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202693-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202693-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202693-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202693-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202693-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202693-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202693-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202693-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202693-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Acetazolamide

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAZOLAMIDE SODIUM500 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
429ZT169UHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307702Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4dd56001-4941-4ff0-9f30-02a1bcc4fe7eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94b5d997-68ee-d92e-7c04-a34fdb427a66Product name920240509
d0adda24-c2d3-39f8-a845-ede9cd56b2c4Product name620210513
91efc97d-7785-4097-b6cf-4201369f41ebProduct name320190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-831-31Acetazolamide1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,19
23155-831-31Acetazolamide5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-831-31EA - Each23155-8315ad4f775-a44a-43ef-9efa-d2d6c60dad2812023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-831ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20250516_4dd56001-4941-4ff0-9f30-02a1bcc4fe7e.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetazolamideACETAZOLAMIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4dd56001-4941-4ff0-9f30-02a1bcc4fe7e2026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202693
application number: ANDA202693
ndc (product): 23155-831
AcetazolamideACETAZOLAMIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.60f656ff-97b1-4a89-99af-8100483c2bac2025-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202693
application number: ANDA202693

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307702acetaZOLAMIDE 500 MG InjectionPSN4dd56001-4941-4ff0-9f30-02a1bcc4fe7e9
307702acetazolamide 500 MG InjectionSCD4dd56001-4941-4ff0-9f30-02a1bcc4fe7e9
307702acetazolamide (as acetazolamide sodium) 500 MG InjectionSY4dd56001-4941-4ff0-9f30-02a1bcc4fe7e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-831-31231550831311 VIAL, GLASS in 1 CARTON (23155-831-31) / 5 mL in 1 VIAL, GLASS2022-11-152027-09-30NoNoCurrent