Home NDC 53808-0353
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# FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53808-0353-1 Didanosine 30 in 1 BLISTER PACK CAPSULE, DELAYED RELEASE PELLETS 30 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIDANOSINE ACTIVE INGREDIENT K3GDH6OH08 DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 DIDANOSINE ACTIVE MOIETY K3GDH6OH08 DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FERRIC OXIDE INACTIVE INGREDIENT 1K09F3G675 DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 METHACRYLIC ACID INACTIVE INGREDIENT 1CS02G8656 DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-0353 DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 Legacy NDC, 1 package rows 20100813_c9891a49-9820-48fc-a209-04c2ba0b4c1a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0353-1 53808035301 30 in 1 BLISTER PACK Historical