Droxidopa

Product NDC
70771-1610
11-digit product format
707711610
Labeler code
70771
Product ID
70771-1610_2c98c6ce-80d6-4ec5-b0a8-8305bf6ac6eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Droxidopa
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA211818
Marketing category
ANDA
Marketing start
2021-02-19
Substance
DROXIDOPA
Active strength
200 mg/1
Pharmacologic classes
Catecholamines [CS], Increased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Droxidopa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DROXIDOPA200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ7A92W69L7
Rxcui1490026, 1490034, 1490038

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60631d48-5636-440b-b5b6-ec0ca1c1ff07Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1610-9Droxidopa90 in 1 BOTTLECAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1610DROXIDOPA CAPSULE [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 1 package rows20241201_e9894e44-99ff-471a-bcc2-bfecd55a6559.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSNe9894e44-99ff-471a-bcc2-bfecd55a65593
1490034droxidopa 200 MG Oral CapsulePSNe9894e44-99ff-471a-bcc2-bfecd55a65593
1490038droxidopa 300 MG Oral CapsulePSNe9894e44-99ff-471a-bcc2-bfecd55a65593
1490026droxidopa 100 MG Oral CapsuleSCDe9894e44-99ff-471a-bcc2-bfecd55a65593
1490034droxidopa 200 MG Oral CapsuleSCDe9894e44-99ff-471a-bcc2-bfecd55a65593
1490038droxidopa 300 MG Oral CapsuleSCDe9894e44-99ff-471a-bcc2-bfecd55a65593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1610-97077116100990 CAPSULE in 1 BOTTLE (70771-1610-9) 90 capsule2021-02-190000-00-00NoNoCurrent