FDA.reportPublic FDA data

Didanosine

Product NDC
0555-0589
11-digit product format
005550589
Labeler code
0555
Product ID
0555-0589_26a65fcc-62e2-4807-aa52-5bd5cbd6389e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Didanosine
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Teva Pharmaceuticals USA,
Application
ANDA077167
Marketing category
ANDA
Marketing start
2004-12-15
Marketing end
2019-03-31
Substance
DIDANOSINE
Active strength
250 mg/1
Pharmacologic classes
Human Immunodef
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0589-01EA - Each0555-05892e049f15-1491-476b-a5f0-5c862d437ab012012-07-24

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
DIDANOSINEACTIVE INGREDIENTK3GDH6OH08DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
DIDANOSINEACTIVE MOIETYK3GDH6OH08DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71ODIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [PHYSICIANS TOTAL CARE, INC.]1

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
284184didanosine 250 MG Delayed Release Oral CapsulePSN829e744d-7bd4-43dc-9b58-ffb016cb8e671
284184didanosine 250 MG Delayed Release Oral CapsuleSCD829e744d-7bd4-43dc-9b58-ffb016cb8e671
284184ddI 250 MG Delayed Release Oral CapsuleSY829e744d-7bd4-43dc-9b58-ffb016cb8e671
284184dideoxyinosine 250 MG Delayed Release Oral CapsuleSY829e744d-7bd4-43dc-9b58-ffb016cb8e671