DESMOPRESSIN ACETATE spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)

Available from:

Zydus Lifesciences Limited

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Desmopressin acetate nasal solution (nasal spray) is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older. Limitations of Use: Desmopressin acetate nasal solution (nasal spray) is not indicated for: - Treatment of nephrogenic diabetes insipidus, - Treatment of primary nocturnal enuresis [see Warnings and Precautions (5.1) ], - Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2)]. - Use in patients with an impaired level of consciousness, - Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths (3)]. Desmopressin acetate nasal solution (nasal spray) is contraindicated in patients with: -   Known hypersensitivity to desmopres

Product summary:

Desmopressin acetate nasal solution (nasal spray), 10 mcg/ 0.1 mL per spray is available in a 5 mL bottle with the spray pump delivering 50 sprays of 10 mcg. NDC 70771-1314-1 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. STORE BOTTLE IN UPRIGHT POSITION.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE SPRAY
ZYDUS LIFESCIENCES LIMITED
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DESMOPRESSIN ACETATE NASAL SOLUTION (NASAL SPRAY)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1314-1
Desmopressin Acetate Nasal Solution (Nasal Spray), 10 mcg/ 0.1 mL per
spray
5 mL
Rx only
DESMOPRESSIN ACETATE
desmopressin acetate spray
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1314
ROUTE OF ADMINISTRATION
NASAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN -
UNII:ENR1LLB0FP)
DESMOPRESSIN
ACETATE
0.1 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
Zydus Lifesciences Limited
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1314-1
5 mL in 1 BOTTLE, SPRAY; Type 0: Not a
Combination Product
02/01/2018
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA091345
02/01/2018
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(70771-1314) , MANUFACTURE(70771-1314)
Revised: 10/2022