Desmopressin Acetate

Product NDC: 24208-342
11-digit product format: 242080342
Labeler code: 24208
Product ID: 24208-342_9b136f48-dd6b-401e-9b91-bdd6ca7e478a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desmopressin Acetate
Dosage form: SOLUTION
Route: NASAL
Labeler: Bauch & Lomb Incorporated
Application: ANDA074830
Marketing category: ANDA
Marketing start: 1999-01-25
Substance: DESMOPRESSIN ACETATE
Active strength: .1 mg/mL
Pharmacologic classes: Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
DESMOPRESSIN ACETATE	.1 mg/mL

Field, Values table
Field	Values
Unii	XB13HYU18U
Rxcui	849506

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bde14c5d-9a3e-43bd-a8e6-0fb00287bdac	Product name	6	20250127
64db728f-18f9-4c58-ba09-60fd6f75f709	Product name	2	20190613
aa3ade84-795a-4f84-bfdf-ebe397f656f5	Product name	1	20190402
d8c9f9fc-e302-45b4-9b21-a802f2592402	Product name	1	20180810
4bbcef53-5c79-462a-b7ba-cff48fe1fb5a	Product name	1	20171129
74cda04a-3bd1-4535-800b-d9b9265e3211	Product name	2	20171129
50d55b09-49b8-f134-6bdc-eb6402b911dc	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24208-342-05	Desmopressin Acetate	1 in 1 CARTON	SOLUTION	1		16
24208-342-05	Desmopressin Acetate	5 mL in 1 BOTTLE, PUMP	SOLUTION	5		16

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-342-05	ML - Milliliter	24208-342	aeb3e8b7-fadd-4450-bb22-dc026425f686	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DESMOPRESSIN ACETATE	ACTIVE INGREDIENT	XB13HYU18U	DESMOPRESSIN ACETATE SOLUTION [BAUCH & LOMB INCORPORATED]	6
DESMOPRESSIN	ACTIVE MOIETY	ENR1LLB0FP	DESMOPRESSIN ACETATE SOLUTION [BAUCH & LOMB INCORPORATED]	6
CHLOROBUTANOL	INACTIVE INGREDIENT	HM4YQM8WRC	DESMOPRESSIN ACETATE SOLUTION [BAUCH & LOMB INCORPORATED]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	DESMOPRESSIN ACETATE SOLUTION [BAUCH & LOMB INCORPORATED]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DESMOPRESSIN ACETATE SOLUTION [BAUCH & LOMB INCORPORATED]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	DESMOPRESSIN ACETATE SOLUTION [BAUCH & LOMB INCORPORATED]	6
DESMOPRESSIN ACETATE	ACTIVE INGREDIENT	XB13HYU18U	DESMOPRESSIN ACETATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
DESMOPRESSIN	ACTIVE MOIETY	ENR1LLB0FP	DESMOPRESSIN ACETATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
CHLOROBUTANOL	INACTIVE INGREDIENT	HM4YQM8WRC	DESMOPRESSIN ACETATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	DESMOPRESSIN ACETATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DESMOPRESSIN ACETATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DESMOPRESSIN ACETATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-342	DESMOPRESSIN ACETATE SOLUTION [BAUCH & LOMB INCORPORATED]	15	Current NDC, Legacy NDC, 2 package rows	20210918_8ca799f1-7029-4527-9ab4-7512504bb8e2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XB13HYU18U	DESMOPRESSIN ACETATE	62357-86-2	DESMOPRESSIN ACETATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849506	desmopressin acetate 0.01 % Nasal Spray	PSN	8ca799f1-7029-4527-9ab4-7512504bb8e2	16
849506	desmopressin acetate 0.01 MG/ACTUAT Nasal Spray	SCD	8ca799f1-7029-4527-9ab4-7512504bb8e2	16
849506	desmopressin acetate 0.01 % Nasal Spray	SY	8ca799f1-7029-4527-9ab4-7512504bb8e2	16
849506	desmopressin acetate 10 MCG per 0.1 ML Nasal Spray	SY	8ca799f1-7029-4527-9ab4-7512504bb8e2	16
849506	desmopressin acetate 10 MCG/ACTUAT Nasal Spray	SY	8ca799f1-7029-4527-9ab4-7512504bb8e2	16
849506	desmopressin acetate 0.01 % Nasal Spray	PSN	b3b68b3a-aa82-4464-8146-51d27861023d	1
849506	desmopressin acetate 0.01 MG/ACTUAT Nasal Spray	SCD	b3b68b3a-aa82-4464-8146-51d27861023d	1
849506	desmopressin acetate 0.01 % Nasal Spray	SY	b3b68b3a-aa82-4464-8146-51d27861023d	1
849506	desmopressin acetate 10 MCG per 0.1 ML Nasal Spray	SY	b3b68b3a-aa82-4464-8146-51d27861023d	1
849506	desmopressin acetate 10 MCG/ACTUAT Nasal Spray	SY	b3b68b3a-aa82-4464-8146-51d27861023d	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-342-05	24208034205	1 BOTTLE, PUMP in 1 CARTON (24208-342-05) / 5 mL in 1 BOTTLE, PUMP	1999-01-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desmopressin Acetate	Bauch & Lomb Incorporated \| Bausch Health Companies Inc.	2021-09-01	HUMAN PRESCRIPTION DRUG LABEL	16
Desmopressin Acetate Nasal Solution, 0.01%	Physicians Total Care, Inc.	2011-02-18	HUMAN PRESCRIPTION DRUG LABEL	1