Home NDC 0143-9443 Colistimethate
Product NDC 0143-9443
11-digit product format 001439443
Labeler code 0143
Product ID 0143-9443_a6b19fc2-67bd-4f3d-bcfa-155aeb0d4aca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colistimethate Sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA205356
Marketing category ANDA
Marketing start 2026-03-04
Substance COLISTIMETHATE SODIUM
Active strength 150 mg/1
Pharmacologic classes Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A205356-001 COLISTIMETHATE SODIUM COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP RS 2015-05-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205356-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP RS 2015-05-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP RS 2015-05-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205356-001 COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE / INJECTION AP 2015-05-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Colistimethate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COLISTIMETHATE SODIUM 150 mg/1
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 0143-9443-01 Colistimethate 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 7 0143-9443-01 Colistimethate 1 in 1 VIAL, GLASS INJECTION, POWDER, FOR SOLUTION 1 7 0143-9443-12 Colistimethate 1 in 1 VIAL, GLASS INJECTION, POWDER, FOR SOLUTION 1 7 0143-9443-12 Colistimethate 12 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 12 7
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 Marketing start Sample Exclude flag Status 0143-9443-01 00143944301 1 VIAL, GLASS in 1 CARTON (0143-9443-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS 2026-03-04 No No Current 0143-9443-12 00143944312 12 VIAL, GLASS in 1 CARTON (0143-9443-12) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS 2026-03-04 No No Current