Colistimethate

Product NDC: 39822-0615
Requested package NDC: 39822-0615-2
11-digit product format: 398220615
Labeler code: 39822
Product ID: 39822-0615_eedca302-5a83-6a5c-e053-2a95a90a7144
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colistimethate
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: XGen Pharmaceuticals DJB, Inc.
Application: ANDA064216
Marketing category: ANDA
Marketing start: 2011-01-01
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: 2023-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	39822-0615	39822-0615-2	D	Discontinued by firm		2026-07-31

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A064216-001	COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION			1999-02-26

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A064216-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION			1999-02-26	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
39822-0615-1	EA - Each	39822-0615	89dc5ae6-32bf-4179-81e4-881f6b8e0b3e	1	2012-07-24
39822-0615-2	EA - Each	39822-0615	c62bf5b1-30ec-40ff-b10c-db6fe3bff98a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COLISTIMETHATE SODIUM	ACTIVE INGREDIENT	XW0E5YS77G	COLISTIMETHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]	22
COLISTIMETHATE	ACTIVE MOIETY	DL2R53P963	COLISTIMETHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]	22
WATER	INACTIVE INGREDIENT	059QF0KO0R	COLISTIMETHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]	22

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XW0E5YS77G	COLISTIMETHATE SODIUM	8068-28-8	COLISTIMETHATE SODIUM
DL2R53P963	COLISTIMETHATE	12705-41-8	Colistimethate

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
39822-0615-2	39822061502	12 CARTON in 1 CARTON (39822-0615-2) > 1 VIAL in 1 CARTON (39822-0615-1) > 2 mL in 1 VIAL	12 carton	2011-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colistimethate for Injection, USP Rx Only FOR INTRAMUSCULAR AND INTRAVENOUS USE	XGen Pharmaceuticals DJB, Inc.	2022-12-02	HUMAN PRESCRIPTION DRUG LABEL	25