Desmopressin Acetate

Product NDC: 68462-276
11-digit product format: 684620276
Labeler code: 68462
Product ID: 68462-276_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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68462-276		D	Discontinued by firm	2026-10-16
excluded package	package	68462-276	68462-276-01	D	Discontinued by firm	2026-10-16
excluded package	package	68462-276	68462-276-10	D	Discontinued by firm	2026-10-16
excluded package	package	68462-276	68462-276-30	D	Discontinued by firm	2026-10-16
excluded package	package	68462-276	68462-276-90	D	Discontinued by firm	2026-10-16

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 2 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A201831-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201831-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201831-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201831-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201831-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201831-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201831-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201831-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201831-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201831-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201831-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201831-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201831-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201831-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201831-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201831-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201831-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201831-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201831-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201831-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201831-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201831-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201831-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201831-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201831-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201831-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201831-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201831-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201831-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201831-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201831-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201831-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201831-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201831-002	AB	1	`cb3db0bc1861…`

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
68462-276-01	Desmopressin Acetate	100 in 1 BOTTLE	TABLET	100	5
68462-276-10	Desmopressin Acetate	1000 in 1 BOTTLE	TABLET	1000	5
68462-276-30	Desmopressin Acetate	30 in 1 BOTTLE	TABLET	30	5
68462-276-90	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
68462-276-01	EA - Each	68462-276	4bdd2257-586e-4cd3-b9c7-4f30101c1048	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
68462-276	DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA]	5	Legacy NDC, 4 package rows	20240104_7a26b415-77cd-4b2f-9c76-fa52d2eb6be6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desmopressin Acetate	DESMOPRESSIN ACETATE	Glenmark Pharmaceuticals Inc.,USA	7a26b415-77cd-4b2f-9c76-fa52d2eb6be6	2019-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201831 application number: ANDA201831 ndc (product): 68462-276

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
68462-276-01	68462027601	100 TABLET in 1 BOTTLE (68462-276-01)	100 tablet	2015-05-28	0000-00-00	No	No	Current
68462-276-10	68462027610	1000 TABLET in 1 BOTTLE (68462-276-10)	1000 tablet	2015-05-28	0000-00-00	No	No	Current
68462-276-30	68462027630	30 TABLET in 1 BOTTLE (68462-276-30)	30 tablet	2015-05-28	0000-00-00	No	No	Current
68462-276-90	68462027690	90 TABLET in 1 BOTTLE (68462-276-90)	90 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	REMEDYREPACK INC.	2023-03-17	HUMAN PRESCRIPTION DRUG LABEL	2
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