Home NDC 70594-023 Colistimethate
Product NDC 70594-023
11-digit product format 705940023
Labeler code 70594
Product ID 70594-023_89aaab5f-68ab-4848-b9c6-a4e1051aaf4c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name colistimethate sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Xellia Pharmaceuticals USA LLC
Application ANDA205356
Marketing category ANDA
Marketing start 2022-02-20
Substance COLISTIMETHATE SODIUM
Active strength 150 mg/1
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 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 2026-12-31 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 70594-023-01 Colistimethate 1 in 1 VIAL, GLASS INJECTION, POWDER, FOR SOLUTION 1 5 70594-023-01 Colistimethate 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 5 70594-023-04 Colistimethate 12 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 12 5 70594-023-04 Colistimethate 1 in 1 VIAL, GLASS INJECTION, POWDER, FOR SOLUTION 1 5 70594-023-09 Colistimethate 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 3 70594-023-09 Colistimethate 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70594-023 COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] 4 Current NDC, Legacy NDC, 4 package rows 20240913_8ec7dc90-825c-422e-9f4b-c8ace9d93af5.zip 70594-023 COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] 3 Current NDC, Legacy NDC, 2 package rows 20240831_13dc3525-1879-4bd8-a922-81bc1397d5af.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 70594-023-01 70594002301 1 VIAL, GLASS in 1 VIAL (70594-023-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS 2018-10-01 0000-00-00 No No Current 70594-023-04 70594002304 12 VIAL, GLASS in 1 CARTON (70594-023-04) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS 2018-10-01 0000-00-00 No No Current 70594-023-09 70594002309 1 VIAL in 1 CARTON (70594-023-09) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 1 vial 2022-02-20 0000-00-00 No No Current