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Desmopressin Acetate

Desmporessin Acetate Tablets 0.1 mg, 0.2 mg

Approved
Approval ID

72aeef35-c102-b628-0219-9822651887eb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 17, 2025

Manufacturers
FDA

Apotex Corp.

DUNS: 845263701

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

desmopressin acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-0258
Application NumberANDA077414
Product Classification
M
Marketing Category
C73584
G
Generic Name
desmopressin acetate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (4)

DESMOPRESSIN ACETATEActive
Quantity: 0.2 mg in 1 1
Code: XB13HYU18U
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

desmopressin acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-0257
Application NumberANDA077414
Product Classification
M
Marketing Category
C73584
G
Generic Name
desmopressin acetate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (4)

DESMOPRESSIN ACETATEActive
Quantity: 0.1 mg in 1 1
Code: XB13HYU18U
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/24/2024

PRINCIPAL DISPLAY PANEL - 0.2 mg BOTTLE LABEL

APOTEX CORP. NDC 60505-0258-3

Desmopressin Acetate Tablets

0.2 mg

Rx

30 bottle count

DesmoporessinAcetete0.2mg

DESCRIPTION SECTION

LOINC: 34089-3Updated: 11/7/2006

DESCRIPTION

Desmopressin Acetate Tablets are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:

Mol. Wt. 1129.27

Empirical Formula: C46H64N14O12S2 • C2H4O2

desmo-image01

where 1<x<1.5

1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt).

Desmopressin acetate tablets, for oral administration, contain either 0.1 or 0.2 mg desmopressin acetate. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, and magnesium stearate.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/24/2024

APOTEX INC.

DESMOPRESSIN ACETATE TABLETS

0.1 mg and 0.2 mg

Manufactured by: Manufactured for:

Apotex Inc. Apotex Corp.

Toronto, Ontario Weston, Florida

Canada M9L 1T9 33326

Revised: October 2008

Rev. 4

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