FDA.reportPublic FDA data

Acetazolamide

Product NDC
25021-839
11-digit product format
250210839
Labeler code
25021
Product ID
25021-839_2b64b799-67b1-41b7-ad0d-7c160c6efd58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA219775
Marketing category
ANDA
Marketing start
2026-01-15
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
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219775-001ACETAZOLAMIDE SODIUMACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2025-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219775-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219775-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2025-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219775-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2025-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A219775-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2025-06-176a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219775-001ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2025-06-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219775-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219775-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219775-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219775-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Acetazolamide
Listing expiration
2027-12-31

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
58093032-8480-4d0f-82be-92e643bdbea4Available 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
25021-839-20Acetazolamide5 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION51
25021-839-20Acetazolamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-839-20EA - Each25021-839725bb3a8-9ef6-4f07-a018-c87587e90da312026-03-17

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
AcetazolamideACETAZOLAMIDE SODIUMSagent Pharmaceuticals58093032-8480-4d0f-82be-92e643bdbea42026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219775
application number: ANDA219775
ndc (product): 25021-839
AcetazolamideACETAZOLAMIDEGland Pharma Limited2b9fb0dd-e42e-4f9b-bf24-98b268d877e52025-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219775
application number: ANDA219775

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307702acetaZOLAMIDE 500 MG InjectionPSN58093032-8480-4d0f-82be-92e643bdbea41
307702acetazolamide 500 MG InjectionSCD58093032-8480-4d0f-82be-92e643bdbea41
307702acetazolamide (as acetazolamide sodium) 500 MG InjectionSY58093032-8480-4d0f-82be-92e643bdbea41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-839-20250210839201 VIAL in 1 CARTON (25021-839-20) / 5 mL in 1 VIAL1 vial2026-01-15NoNoCurrent