Desmopressin Acetate

Product NDC: 68462-275
Requested package NDC: 68462-275-30
11-digit product format: 684620275
Labeler code: 68462
Product ID: 68462-275_4d4ec9b1-dee2-4056-97da-1d46b2843481
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desmopressin Acetate
Dosage form: TABLET
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc.,USA
Application: ANDA201831
Marketing category: ANDA
Marketing start: 2015-05-28
Marketing end: 0000-00-00
Substance: DESMOPRESSIN ACETATE
Active strength: 0 mg/1
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68462-275	68462-275-30	D	Discontinued by firm		2026-11-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201831-001	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL			2015-05-28
A201831-002	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL			2015-05-28

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.

Product history page 1 of 3 · 88 observed 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
2026-10-15 13:18:30	2026-09	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2015-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2015-05-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2015-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2015-05-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2015-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2015-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2015-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2015-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2015-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201831-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2015-05-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201831-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2015-05-28	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201831-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201831-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201831-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201831-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201831-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201831-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201831-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201831-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201831-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201831-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201831-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201831-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201831-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201831-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201831-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201831-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201831-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201831-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201831-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201831-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201831-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201831-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201831-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201831-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201831-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201831-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201831-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201831-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201831-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201831-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201831-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201831-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201831-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201831-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201831-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201831-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201831-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201831-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201831-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201831-002	AB	1	`8869cabd3fbd…`

Reported adverse events (FAERS/openFDA)#

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

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
68462-275-01	Desmopressin Acetate	100 in 1 BOTTLE	TABLET	100	5
68462-275-10	Desmopressin Acetate	1000 in 1 BOTTLE	TABLET	1000	5
68462-275-30	Desmopressin Acetate	30 in 1 BOTTLE	TABLET	30	5
68462-275-90	Desmopressin Acetate	90 in 1 BOTTLE	TABLET	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-275-01	EA - Each	68462-275	f9e4b159-1fd1-492e-afca-02223890893c	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DESMOPRESSIN ACETATE	ACTIVE INGREDIENT	XB13HYU18U	DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA]	2
DESMOPRESSIN	ACTIVE MOIETY	ENR1LLB0FP	DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA]	2
STARCH, POTATO	INACTIVE INGREDIENT	8I089SAH3T	DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-275	DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA]	5	Legacy NDC, 4 package rows	20240104_7a26b415-77cd-4b2f-9c76-fa52d2eb6be6.zip

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
849515	desmopressin acetate 0.1 MG Oral Tablet	PSN	7a26b415-77cd-4b2f-9c76-fa52d2eb6be6	5
833008	desmopressin acetate 0.2 MG Oral Tablet	PSN	7a26b415-77cd-4b2f-9c76-fa52d2eb6be6	5
849515	desmopressin acetate 0.1 MG Oral Tablet	SCD	7a26b415-77cd-4b2f-9c76-fa52d2eb6be6	5
833008	desmopressin acetate 0.2 MG Oral Tablet	SCD	7a26b415-77cd-4b2f-9c76-fa52d2eb6be6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-275-30	68462027530	30 TABLET in 1 BOTTLE (68462-275-30)	30 tablet	2015-05-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desmopressin Acetate Tablets, 0.1 mg and 0.2 mg	Glenmark Pharmaceuticals Inc.,USA \| Glenmark Pharmaceuticals Ltd.	2019-06-28	HUMAN PRESCRIPTION DRUG LABEL	5