Desmopressin Acetate

Product NDC: 83634-451
11-digit product format: 836340451
Labeler code: 83634
Product ID: 83634-451_0181c37e-c05d-47c4-bf3d-126c84bbf063
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: desmopressin acetate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Avenacy, Inc.
Application: ANDA210223
Marketing category: ANDA
Marketing start: 2024-01-15
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 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
A210223-001	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP		2020-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210223-001	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
2026-02-19 14:30 UTC	2026-02	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210223-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210223-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210223-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210223-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210223-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210223-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210223-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210223-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210223-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210223-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210223-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210223-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210223-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210223-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210223-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210223-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210223-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210223-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210223-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210223-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210223-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210223-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210223-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210223-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210223-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210223-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210223-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210223-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210223-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210223-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210223-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210223-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210223-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210223-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210223-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210223-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210223-001	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849501	Internal RxNorm lookup
1723232	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
c2e21331-4d54-4fa7-8f0d-31fe23a981aa	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	SPL version
83634-451-01	Desmopressin Acetate	10 in 1 CARTON	INJECTION, SOLUTION	10	1
83634-451-10	Desmopressin Acetate	1 in 1 CARTON	INJECTION, SOLUTION	1	1
83634-451-10	Desmopressin Acetate	10 mL in 1 VIAL	INJECTION, SOLUTION	10	1
83634-451-41	Desmopressin Acetate	1 mL in 1 VIAL	INJECTION, SOLUTION	1	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83634-451-01	ML - Milliliter	83634-451	ccf961d7-d672-4c0b-85a8-6845ce528802	1	2024-04-05
83634-451-10	ML - Milliliter	83634-451	2653770d-d9b5-4127-91b7-4d37886ec193	1	2024-04-05
83634-451-41	ML - Milliliter	83634-451	d1e00168-80b3-4605-a7eb-980c4c813f98	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83634-451	DESMOPRESSIN ACETATE INJECTION, SOLUTION [AVENACY, INC.]	1	Current NDC, 4 package rows	20240115_c2e21331-4d54-4fa7-8f0d-31fe23a981aa.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	UBI Pharma Inc.	b01c22dc-eecd-11b2-e053-2a95a90a529a	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210223 application number: ANDA210223
Desmopressin Acetate	DESMOPRESSIN ACETATE	XGen Pharmaceuticals DJB, Inc.	1052a869-b64d-655d-e063-6294a90ad0e2	2024-03-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210223 application number: ANDA210223
Desmopressin Acetate	DESMOPRESSIN ACETATE	Avenacy, Inc.	c2e21331-4d54-4fa7-8f0d-31fe23a981aa	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210223 application number: ANDA210223 ndc (product): 83634-451

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
1723232	desmopressin acetate 4 MCG in 1 ML Injection	PSN	c2e21331-4d54-4fa7-8f0d-31fe23a981aa	1
849501	desmopressin acetate 4 MCG/ML Injectable Solution	PSN	c2e21331-4d54-4fa7-8f0d-31fe23a981aa	1
1723232	1 ML desmopressin acetate 0.004 MG/ML Injection	SCD	c2e21331-4d54-4fa7-8f0d-31fe23a981aa	1
849501	desmopressin acetate 0.004 MG/ML Injectable Solution	SCD	c2e21331-4d54-4fa7-8f0d-31fe23a981aa	1
1723232	desmopressin acetate 4 MCG per 1 ML Injection	SY	c2e21331-4d54-4fa7-8f0d-31fe23a981aa	1
849501	desmopressin acetate 4 MCG/ML Injectable Solution	SY	c2e21331-4d54-4fa7-8f0d-31fe23a981aa	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83634-451-01	83634045101	10 VIAL in 1 CARTON (83634-451-01) / 1 mL in 1 VIAL (83634-451-41)	10 vial	2024-01-15	No	No	Current
83634-451-10	83634045110	1 VIAL in 1 CARTON (83634-451-10) / 10 mL in 1 VIAL	1 vial	2024-01-15	No	No	Current
83634-451-41	83634045141	1 mL in 1 VIAL	1 ml				Historical