Desmopressin Acetate

Product NDC: 83148-126
11-digit product format: 831480126
Labeler code: 83148
Product ID: 83148-126_5a144051-0656-4da5-e063-6294a90a18cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desmopressin Acetate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: The J. Molner Company LLC
Application: ANDA210223
Marketing category: ANDA
Marketing start: 2026-08-11
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
2026-09-14 22:38:34	2026-08	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210223-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2020-09-17	`caaa826d4ba7…`
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
2026-09-14 22:38:34	2026-08	A210223-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210223-001	AP	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Desmopressin Acetate
Listing expiration: 2027-12-31

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
52680415-52a0-61c2-e063-6294a90ae27e	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desmopressin Acetate	DESMOPRESSIN ACETATE	The J. Molner Company LLC	52680415-52a0-61c2-e063-6294a90ae27e	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210223 application number: ANDA210223 ndc (product): 83148-126
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83148-126-01	83148012601	1 VIAL in 1 CARTON (83148-126-01) / 10 mL in 1 VIAL	1 vial	2026-08-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desmopressin Acetate	The J. Molner Company LLC \| UBI Pharma	2026-08-27	HUMAN PRESCRIPTION DRUG LABEL	2