Acetazolamide

Manufacturer: Zydus Lifesciences Limited
Effective date: 2022-10-17
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 21:51:18

Label at a glance#

ProductAcetazolamide

Active ingredientACETAZOLAMIDE SODIUM

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label

NDC 70771-1490-1

AcetaZOLAMIDE for Injection USP

500 mg* per vial

For Intravenous Use

1 Single-Dose Vial

Rx Only

Carton Label

NDC 70771-1490-1

AcetaZOLAMIDE for Injection USP

500 mg* per vial

For Intravenous Use

1 Single-Dose Vial

Rx Only

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1490	ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED]	3	Legacy NDC	20221019_1269804e-7d32-466c-83e7-99e6ddceb8b2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Acetazolamide
ACETAZOLAMIDE SODIUM
SODIUM HYDROXIDE
HYDROCHLORIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1490	70771-1490-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAZOLAMIDE SODIUM	429ZT169UH	ACTIM
SODIUM HYDROXIDE	55X04QC32I	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A206533-001	ACETAZOLAMIDE SODIUM	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2019-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206533-001	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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206533-001	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-04-15	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A206533-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206533-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206533-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206533-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206533-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206533-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206533-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206533-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206533-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206533-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206533-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206533-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206533-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206533-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206533-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206533-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206533-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206533-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206533-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206533-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206533-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206533-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206533-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206533-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206533-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206533-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206533-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206533-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206533-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206533-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206533-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206533-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206533-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206533-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206533-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206533-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206533-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206533-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206533-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206533-001	AP	1	`3a93d1ddd44b…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bd3062e3-d05b-44e8-b5f6-67305c21ab03			1269804e-7d32-466c-83e7-99e6ddceb8b2	2025-05-31		Exact identifier spl set id: 1269804e-7d32-466c-83e7-99e6ddceb8b2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.