FDA.reportPublic FDA data

NDC 68084-604-11 - Desmopressin Acetate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68084-604
Requested NDC
68084-604-11
Package NDCs from labels
68084-604-11, 68084-604-21
Manufacturer
American Health Packaging
Effective date
2023-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Desmopressin Acetate - American Health PackagingAmerican Health Packaging2023-03-20HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-604-11EA - Each68084-60407e9593c-eb20-4356-9097-50ed4b0e74e212013-02-13
68084-604-21EA - Each68084-604a3224d68-9c24-4db0-bb17-c91fd7b6b00112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESMOPRESSIN ACETATEACTIVE INGREDIENTXB13HYU18UDESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING]3
DESMOPRESSINACTIVE MOIETYENR1LLB0FPDESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KDESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EDESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING]3
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TDESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING]3

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 6 of 6 · 108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desmopressin AcetateDESMOPRESSIN ACETATESun Pharmaceutical Industries, Inc.9fd48eec-aa24-4888-b99f-d409ada958a72022-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XB13HYU18U
Desmopressin AcetateDESMOPRESSIN ACETATEDr. Reddy's Laboratories Inc.60dd8694-58d8-d88e-26f2-f28baa53787e2022-07-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XB13HYU18U
Desmopressin AcetateDESMOPRESSIN ACETATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.e87b6cfd-5677-4398-883d-7ced5dd678ef2022-03-30Warnings, Adverse reactionsExact identifier
unii: XB13HYU18U
Desmopressin AcetateDESMOPRESSIN ACETATEBauch & Lomb Incorporated8ca799f1-7029-4527-9ab4-7512504bb8e22021-09-01Warnings, Adverse reactionsExact identifier
unii: XB13HYU18U
DDAVPDESMOPRESSIN ACETATEFerring Pharmaceuticals Inc.6d55baa9-2b62-469c-93ae-3909ab2493322021-02-03Warnings, Adverse reactionsExact identifier
unii: XB13HYU18U
desmopressin acetateDESMOPRESSIN ACETATESun Pharmaceutical Industries, Inc.2dc2cec8-6953-4a33-9356-11534fba1fb82020-01-23Warnings, Adverse reactionsExact identifier
unii: XB13HYU18U
DESMOPRESSIN ACETATEDESMOPRESSIN ACETATEDr.Reddys' Laboratories Inc15179e0c-f677-307f-d1e1-5910de4c212f2019-11-30Warnings, Adverse reactionsExact identifier
unii: XB13HYU18U
Desmopressin AcetateDESMOPRESSIN ACETATEGlenmark Pharmaceuticals Inc.,USA7a26b415-77cd-4b2f-9c76-fa52d2eb6be62019-06-28Warnings, Adverse reactionsExact identifier
unii: XB13HYU18U

Reported adverse events (FAERS/openFDA)#

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