Home NDC 63323-658 Chlorothiazide
Product NDC 63323-658
11-digit product format 633230658
Labeler code 63323
Product ID 63323-658_85e1af90-9f5e-44a1-8bc3-5868be35812b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CHLOROTHIAZIDE SODIUM
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA090896
Marketing category ANDA
Marketing start 2009-10-21
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090896-001 CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090896-001 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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090896-001 CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-10-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Chlorothiazide
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-658-20 Chlorothiazide 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 6 63323-658-20 Chlorothiazide 18 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 18 6 63323-658-94 Chlorothiazide 18 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 18 5 63323-658-94 Chlorothiazide 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 5 63323-658-27 Chlorothiazide 18 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 18 4 63323-658-27 Chlorothiazide 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLOROTHIAZIDE SODIUM ACTIVE INGREDIENT SN86FG7N2K CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 CHLOROTHIAZIDE SODIUM ACTIVE INGREDIENT SN86FG7N2K CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 CHLOROTHIAZIDE SODIUM ACTIVE INGREDIENT SN86FG7N2K CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1 CHLOROTHIAZIDE ACTIVE MOIETY 77W477J15H CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 CHLOROTHIAZIDE ACTIVE MOIETY 77W477J15H CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 CHLOROTHIAZIDE ACTIVE MOIETY 77W477J15H CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-658 CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20250409_de512e9b-444c-4ae4-8c6b-accd87a02021.zip 63323-658 CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20230613_de250776-461a-4d02-a82e-ffedca1a9cf4.zip 63323-658 CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20230613_5b5d8a97-1428-4047-8e6c-b778429a26e4.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-658-20 63323065820 1 VIAL in 1 BOX (63323-658-20) / 18 mL in 1 VIAL 1 vial 2009-10-21 0000-00-00 No No Current 63323-658-27 63323065827 1 VIAL in 1 BOX (63323-658-27) / 18 mL in 1 VIAL 1 vial 2009-10-21 0000-00-00 No No Current 63323-658-94 63323065894 1 VIAL in 1 BOX (63323-658-94) / 18 mL in 1 VIAL 1 vial 2009-10-21 0000-00-00 No No Current