CHLOROTHIAZIDE SODIUM

Product NDC: 47335-330
Requested package NDC: 47335-330-40
11-digit product format: 473350330
Labeler code: 47335
Product ID: 47335-330_dda0054a-e39b-4667-addf-e999a34806d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLOROTHIAZIDE SODIUM
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA091546
Marketing category: ANDA
Marketing start: 2016-08-25
Substance: CHLOROTHIAZIDE SODIUM
Active strength: 500 mg/18mL
Pharmacologic classes: Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [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 1.

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
A091546-001	CHLOROTHIAZIDE SODIUM	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2011-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091546-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2011-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2011-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2011-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2011-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091546-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091546-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091546-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091546-001	AP	1	`6a471c1ec25d…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091546-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091546-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091546-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091546-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091546-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091546-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091546-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091546-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091546-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091546-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091546-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091546-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091546-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091546-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091546-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091546-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091546-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091546-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091546-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091546-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091546-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091546-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091546-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091546-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091546-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091546-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091546-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091546-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091546-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091546-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091546-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091546-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091546-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091546-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: CHLOROTHIAZIDE SODIUM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLOROTHIAZIDE SODIUM	500 mg/18mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SN86FG7N2K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
484152	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
187240e9-1eed-45ec-befb-18647d175112	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3d305018-7d41-42ea-a6eb-85f5b05f9a63	Product name	3	20250429
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
6823a9b2-3fe6-2173-aeb8-21d965ee1e1e	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47335-330-40	CHLOROTHIAZIDE SODIUM	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		5
47335-330-40	CHLOROTHIAZIDE SODIUM	18 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	18		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-330-40	EA - Each	47335-330	bc490365-3217-44af-bef9-817571da1c9a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLOROTHIAZIDE SODIUM	ACTIVE INGREDIENT	SN86FG7N2K	CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]	2
CHLOROTHIAZIDE	ACTIVE MOIETY	77W477J15H	CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-330	CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20250323_187240e9-1eed-45ec-befb-18647d175112.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLOROTHIAZIDE SODIUM	CHLOROTHIAZIDE SODIUM	Sun Pharmaceutical Industries, Inc.	187240e9-1eed-45ec-befb-18647d175112	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091546 application number: ANDA091546 ndc (package): 47335-330-40 ndc (product): 47335-330 ndc11 (package): 47335033040

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SN86FG7N2K	CHLOROTHIAZIDE SODIUM	7085-44-1	CHLOROTHIAZIDE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
484152	chlorothiazide 500 MG Injection	PSN	187240e9-1eed-45ec-befb-18647d175112	5
484152	chlorothiazide 500 MG Injection	SCD	187240e9-1eed-45ec-befb-18647d175112	5
484152	chlorothiazide (as chlorothiazide sodium) 0.5 GM Injection	SY	187240e9-1eed-45ec-befb-18647d175112	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-330-40	47335033040	1 VIAL, SINGLE-DOSE in 1 CARTON (47335-330-40) / 18 mL in 1 VIAL, SINGLE-DOSE	2016-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorothiazide Sodium for Injection, USP FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited \| Immacule Lifesciences Private Limited	2025-03-21	Human Prescription Drug Label	5