Acetazolamide

Product NDC
72162-1979
11-digit product format
721621979
Labeler code
72162
Product ID
72162-1979_86603c34-aacd-401c-b880-9bc505baec29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214282
Marketing category
ANDA
Marketing start
2020-11-13
Substance
ACETAZOLAMIDE
Active strength
250 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214282-001ACETAZOLAMIDEACETAZOLAMIDE125MGTABLET / ORALAB2020-10-07
A214282-002ACETAZOLAMIDEACETAZOLAMIDE250MGTABLET / ORALAB2020-10-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214282-001AB
A214282-002AB

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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-07782e0a99824c…
2021-12-28 21:50 UTC2021-12A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214282-001ACETAZOLAMIDE125MGTABLET / ORALAB2020-10-0787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214282-002ACETAZOLAMIDE250MGTABLET / ORALAB2020-10-0787673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214282-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214282-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214282-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214282-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214282-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214282-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214282-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214282-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214282-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214282-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214282-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214282-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214282-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214282-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214282-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214282-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214282-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214282-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214282-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214282-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214282-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214282-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214282-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214282-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214282-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214282-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214282-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214282-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214282-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214282-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214282-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214282-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214282-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214282-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214282-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214282-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214282-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A214282-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214282-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214282-002AB187673890dc5c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAZOLAMIDE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O3FX965V0IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197304Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
84a582a9-c7e5-4159-a5eb-a47a96b4afc0Available 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
72162-1979-1Acetazolamide100 in 1 BOTTLETABLET100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1979-1EA - Each72162-19798889addf-d272-4d80-96e5-68e58ae43a6812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1979ACETAZOLAMIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20241122_84a582a9-c7e5-4159-a5eb-a47a96b4afc0.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetazolamideACETAZOLAMIDEBryant Ranch Prepack9af15152-d46f-4bc3-a16e-b70a472bc52a2026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214282
application number: ANDA214282
AcetazolamideACETAZOLAMIDEBryant Ranch Prepack84a582a9-c7e5-4159-a5eb-a47a96b4afc02026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214282
application number: ANDA214282
ndc (product): 72162-1979
AcetazolamideACETAZOLAMIDEBryant Ranch Prepackf7227cc5-0a80-47df-baf8-09f1b22b187e2026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214282
application number: ANDA214282
AcetazolamideACETAZOLAMIDELifestar Pharma LLC0913db35-3f08-4d82-8394-486bd9a487c42026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214282
application number: ANDA214282
AcetazolamideACETAZOLAMIDEBryant Ranch Prepack923031ec-8142-4570-b3a6-210441d971052024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214282
application number: ANDA214282

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197304acetaZOLAMIDE 250 MG Oral TabletPSN84a582a9-c7e5-4159-a5eb-a47a96b4afc0102
197304acetazolamide 250 MG Oral TabletSCD84a582a9-c7e5-4159-a5eb-a47a96b4afc0102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1979-172162197901100 TABLET in 1 BOTTLE (72162-1979-1) 100 tablet2020-11-13NoNoCurrent