FDA.reportPublic FDA data

Dextroamphetamine

Product NDC
27808-085
11-digit product format
278080085
Labeler code
27808
Product ID
27808-085_442f3920-82b4-41ab-b485-24954a2ebddb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine
Dosage form
SOLUTION
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA203644
Marketing category
ANDA
Marketing start
2013-05-31
Substance
DEXTROAMPHETAMINE SULFATE
Active strength
5 mg/5mL
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROAMPHETAMINE SULFATE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJJ768O327N
Rxcui884522

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
b4c312b9-fad5-247e-cef9-87a74220463dProduct name520230426
8170729e-5ba4-46f9-830f-5f0fae5942ceProduct name120230103
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27Product name520190913
b4c312b9-fad5-247e-cef9-87a74220463dProduct name420171211
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ffdf7f68-0f44-4dd6-a026-336dcb345fc4Product name120151109
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27808-085-01Dextroamphetamine473 mL in 1 BOTTLE, PLASTICSOLUTION47316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-085-01ML - Milliliter27808-085f51d4926-bbb7-4d55-bb2c-e68d7781bac312013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROAMPHETAMINE SULFATEACTIVE INGREDIENTJJ768O327NDEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]2
DEXTROAMPHETAMINEACTIVE MOIETYTZ47U051FIDEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMDEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]2
SACCHARININACTIVE INGREDIENTFST467XS7DDEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]2
SORBITOLINACTIVE INGREDIENT506T60A25RDEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]2
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-085DEXTROAMPHETAMINE SOLUTION [CRANBURY PHARMACEUTICALS, LLC]15Current NDC, Legacy NDC, 1 package rows20250328_7658071e-ee2c-4d23-94ce-1906959ec036.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884522dextroamphetamine sulfate 5 MG in 5 mL Oral SolutionPSN76da9845-2ce1-49a5-9bf3-6a550d623172102
884522dextroamphetamine sulfate 1 MG/ML Oral SolutionSCD76da9845-2ce1-49a5-9bf3-6a550d623172102
884522dextroamphetamine sulfate 5 MG per 5 ML Oral SolutionSY76da9845-2ce1-49a5-9bf3-6a550d623172102
884522dextroamphetamine sulfate 5 MG in 5 mL Oral SolutionPSN7658071e-ee2c-4d23-94ce-1906959ec03616
884522dextroamphetamine sulfate 1 MG/ML Oral SolutionSCD7658071e-ee2c-4d23-94ce-1906959ec03616
884522dextroamphetamine sulfate 5 MG per 5 ML Oral SolutionSY7658071e-ee2c-4d23-94ce-1906959ec03616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-085-0127808008501473 mL in 1 BOTTLE, PLASTIC (27808-085-01) 473 ml2013-05-310000-00-00NoNoCurrent