Desmopressin Acetate

Product NDC: 70095-031
11-digit product format: 700950031
Labeler code: 70095
Product ID: 70095-031_2a4f6931-2711-4831-8096-7acb266f4e22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desmopressin Acetate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Sun Pharmaceutical Industries Limited
Application: ANDA216904
Marketing category: ANDA
Marketing start: 2023-06-20
Substance: DESMOPRESSIN ACETATE
Active strength: 4 ug/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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A216904-001	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP		2023-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216904-001	AP

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216904-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2023-03-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216904-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216904-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216904-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216904-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216904-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216904-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216904-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216904-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216904-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216904-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216904-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216904-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216904-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216904-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216904-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216904-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216904-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216904-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216904-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216904-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216904-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216904-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216904-001	AP	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216904-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Desmopressin Acetate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESMOPRESSIN ACETATE	4 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XB13HYU18U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849501	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
539d7da2-72b8-45f9-836c-4e3351dd488e	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70095-031-01	Desmopressin Acetate	10 mL in 1 VIAL	INJECTION, SOLUTION	10		3
70095-031-01	Desmopressin Acetate	1 in 1 CARTON	INJECTION, SOLUTION	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70095-031-01	ML - Milliliter	70095-031	4eb2a932-f65a-4ab4-9e01-93c66ced9abe	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70095-031	DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED]	3	Current NDC, 2 package rows	20230621_539d7da2-72b8-45f9-836c-4e3351dd488e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desmopressin Acetate	DESMOPRESSIN ACETATE	Fresenius Kabi USA, LLC	9725ba8e-ac0f-4655-bb98-9ea926142815	2023-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216904 application number: ANDA216904
Desmopressin Acetate	DESMOPRESSIN ACETATE	Sun Pharmaceutical Industries Limited	539d7da2-72b8-45f9-836c-4e3351dd488e	2023-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216904 application number: ANDA216904 ndc (product): 70095-031
Desmopressin Acetate	DESMOPRESSIN ACETATE	Gland Pharma Limited	848d5173-ce26-46bf-b180-7ed13f0233b5	2023-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216904 application number: ANDA216904

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849501	desmopressin acetate 4 MCG/ML Injectable Solution	PSN	539d7da2-72b8-45f9-836c-4e3351dd488e	3
849501	desmopressin acetate 0.004 MG/ML Injectable Solution	SCD	539d7da2-72b8-45f9-836c-4e3351dd488e	3
849501	desmopressin acetate 4 MCG/ML Injectable Solution	SY	539d7da2-72b8-45f9-836c-4e3351dd488e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70095-031-01	70095003101	1 VIAL in 1 CARTON (70095-031-01) / 10 mL in 1 VIAL	1 vial	2023-06-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desmopressin Acetate	Sun Pharmaceutical Industries Limited \| Gland Pharma Limited	2023-06-06	Human Prescription Drug Label	3