Didanosine

Product NDC
53808-0353
11-digit product format
538080353
Labeler code
53808
Product ID
53808-0353_1dc18acf-c100-4c94-a5e5-1ba3e9218bab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Didanosine
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077167
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
DIDANOSINE
Active strength
400 mg/1
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8febbfc6-6c30-da85-968d-d322c652ad79Product name120140508
db886393-0819-e9b6-1414-5642f7e2cea6Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0353-1Didanosine30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE PELLETS302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIDANOSINEACTIVE INGREDIENTK3GDH6OH08DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
DIDANOSINEACTIVE MOIETYK3GDH6OH08DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FERRIC OXIDEINACTIVE INGREDIENT1K09F3G675DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
GELATININACTIVE INGREDIENT2G86QN327LDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WODIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SHELLACINACTIVE INGREDIENT46N107B71ODIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TRIACETININACTIVE INGREDIENTXHX3C3X673DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0353DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20100813_c9891a49-9820-48fc-a209-04c2ba0b4c1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284184didanosine 250 MG Delayed Release Oral CapsulePSNc9891a49-9820-48fc-a209-04c2ba0b4c1a2
284988didanosine 400 MG Delayed Release Oral CapsulePSNc9891a49-9820-48fc-a209-04c2ba0b4c1a2
284184didanosine 250 MG Delayed Release Oral CapsuleSCDc9891a49-9820-48fc-a209-04c2ba0b4c1a2
284988didanosine 400 MG Delayed Release Oral CapsuleSCDc9891a49-9820-48fc-a209-04c2ba0b4c1a2
284184ddI 250 MG Delayed Release Oral CapsuleSYc9891a49-9820-48fc-a209-04c2ba0b4c1a2
284988ddI 400 MG Delayed Release Oral CapsuleSYc9891a49-9820-48fc-a209-04c2ba0b4c1a2
284184dideoxyinosine 250 MG Delayed Release Oral CapsuleSYc9891a49-9820-48fc-a209-04c2ba0b4c1a2
284988dideoxyinosine 400 MG Delayed Release Oral CapsuleSYc9891a49-9820-48fc-a209-04c2ba0b4c1a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0353-15380803530130 in 1 BLISTER PACKHistorical