FDA.reportPublic FDA data

Colistimethate

Product NDC
25021-159
Requested package NDC
25021-159-10
11-digit product format
250210159
Labeler code
25021
Product ID
25021-159_bcb0fe18-a09c-4a1c-950b-094471b77bda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colistimethate sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA201365
Marketing category
ANDA
Marketing start
2014-12-29
Marketing end
0000-00-00
Substance
COLISTIMETHATE SODIUM
Active strength
150 mg/2mL
Pharmacologic classes
Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage25021-15925021-159-10DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A201365-001COLISTIMETHATE SODIUMCOLISTIMETHATE SODIUMEQ 150MG BASE/VIALINJECTABLE / INJECTIONAP2014-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201365-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A201365-001COLISTIMETHATE SODIUMEQ 150MG BASE/VIALINJECTABLE / INJECTIONAP2014-02-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201365-001AP1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-159-10EA - Each25021-1599b7f20ff-7db5-436a-afb5-9c45f8ca7e4a12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
colistimethate sodiumACTIVE INGREDIENTXW0E5YS77GCOLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]6
colistimethateACTIVE MOIETYDL2R53P963COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-159-10250210159101 VIAL in 1 CARTON (25021-159-10) > 2 mL in 1 VIAL1 vial2014-12-290000-00-00NoNoCurrent