Droxidopa

Product NDC
31722-010
11-digit product format
317220010
Labeler code
31722
Product ID
31722-010_c9c062e6-c790-3f45-e053-2995a90aaa67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Droxidopa
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA211726
Marketing category
ANDA
Marketing start
2021-02-18
Substance
DROXIDOPA
Active strength
300 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
DROXIDOPA300 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
31722-010-90Droxidopa90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-010-90EA - Each31722-0101661168e-55bb-4041-b495-33ee01db2a2512021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-010DROXIDOPA (DROXIDOPA) CAPSULE [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20210818_c21ea27c-6e3b-4296-a118-c0b878cdf8f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSNc21ea27c-6e3b-4296-a118-c0b878cdf8f82
1490034droxidopa 200 MG Oral CapsulePSNc21ea27c-6e3b-4296-a118-c0b878cdf8f82
1490038droxidopa 300 MG Oral CapsulePSNc21ea27c-6e3b-4296-a118-c0b878cdf8f82
1490026droxidopa 100 MG Oral CapsuleSCDc21ea27c-6e3b-4296-a118-c0b878cdf8f82
1490034droxidopa 200 MG Oral CapsuleSCDc21ea27c-6e3b-4296-a118-c0b878cdf8f82
1490038droxidopa 300 MG Oral CapsuleSCDc21ea27c-6e3b-4296-a118-c0b878cdf8f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-010-903172200109090 CAPSULE in 1 BOTTLE (31722-010-90) 90 capsule2021-02-180000-00-00NoNoCurrent