Home NDC 68462-276 Desmopressin Acetate
Product NDC 68462-276
11-digit product format 684620276
Labeler code 68462
Product ID 68462-276_d9414e03-41d5-4e96-9ce6-b298c365281d
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
Substance DESMOPRESSIN ACETATE
Active strength .2 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 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 · 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 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2019-12-13 00:20 UTC 2019-12 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
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 .2 mg/1
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 833008 Internal RxNorm lookup 849515 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 Current NDC, 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.
DailyMed RxNorm Mappings# 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