Home NDC 63323-393 Colistimethate
Product NDC 63323-393
11-digit product format 633230393
Labeler code 63323
Product ID 63323-393_4637a207-5042-4af6-a7a7-e63cd472b0d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COLISTIMETHATE SODIUM
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA065364
Marketing category ANDA
Marketing start 2009-12-04
Substance COLISTIMETHATE SODIUM
Active strength 150 mg/2mL
Pharmacologic classes Polymyxin-class Antibacterial [EPC], Polymyxins [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 A065364-001 COLISTIMETHATE SODIUM COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065364-001 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 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065364-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2008-04-17 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 Colistimethate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COLISTIMETHATE SODIUM 150 mg/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XW0E5YS77G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1117522 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 63323-393-06 Colistimethate 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 5 63323-393-06 Colistimethate 2 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 2 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded COLISTIMETHATE SODIUM ACTIVE INGREDIENT XW0E5YS77G COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 COLISTIMETHATE ACTIVE MOIETY DL2R53P963 COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-393 COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20200430_ab241809-0d2f-44ba-829c-26be67ee623f.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.
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 63323-393-06 63323039306 1 VIAL in 1 BOX (63323-393-06) / 2 mL in 1 VIAL 1 vial 2009-12-04 0000-00-00 No No Current