Chlorothiazide Sodium

Product NDC
0517-1820
11-digit product format
005171820
Labeler code
0517
Product ID
0517-1820_2c97dd4f-150c-4fc0-9400-2d8305bb21b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorothiazide Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Application
ANDA202561
Marketing category
ANDA
Marketing start
2015-04-01
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 42.

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
A202561-001CHLOROTHIAZIDE SODIUMCHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202561-001AP

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-223f01610625f2…
2019-09-15 20:21 UTC2019-09A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202561-001CHLOROTHIAZIDE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2013-04-22e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202561-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202561-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202561-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202561-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202561-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202561-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202561-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202561-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202561-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202561-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202561-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202561-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202561-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202561-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202561-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202561-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202561-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202561-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202561-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202561-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202561-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202561-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A202561-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202561-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202561-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202561-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A202561-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202561-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202561-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202561-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202561-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202561-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202561-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202561-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202561-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202561-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202561-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202561-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202561-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202561-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorothiazide Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROTHIAZIDE SODIUM500 mg/18mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SN86FG7N2KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
850960a3-9fe2-4999-81eb-b0ae9ba011bcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d305018-7d41-42ea-a6eb-85f5b05f9a63Product name320250429
6823a9b2-3fe6-2173-aeb8-21d965ee1e1eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-1820-01Chlorothiazide Sodium18 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,186
0517-1820-01Chlorothiazide Sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-1820-01EA - Each0517-18201555e11c-14f8-48f7-82bf-608b89b69dd912015-05-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-1820CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMERICAN REGENT, INC.]6Current NDC, Legacy NDC, 2 package rows20200609_850960a3-9fe2-4999-81eb-b0ae9ba011bc.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlorothiazide SodiumCHLOROTHIAZIDE SODIUMAmerican Regent, Inc.850960a3-9fe2-4999-81eb-b0ae9ba011bc2020-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202561
application number: ANDA202561
ndc (product): 0517-1820

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484152chlorothiazide 500 MG InjectionPSN850960a3-9fe2-4999-81eb-b0ae9ba011bc6
484152chlorothiazide 500 MG InjectionSCD850960a3-9fe2-4999-81eb-b0ae9ba011bc6
484152chlorothiazide (as chlorothiazide sodium) 0.5 GM InjectionSY850960a3-9fe2-4999-81eb-b0ae9ba011bc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-1820-01005171820011 VIAL in 1 CARTON (0517-1820-01) / 18 mL in 1 VIAL1 vial2015-04-010000-00-00NoNoCurrent