NDC 65862-310

Didanosine

Didanosine

Didanosine is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Didanosine.

Product ID65862-310_01d147ed-45ea-4fe4-8429-17d6b806a4f0
NDC65862-310
Product TypeHuman Prescription Drug
Proprietary NameDidanosine
Generic NameDidanosine
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2008-09-24
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA090094
Labeler NameAurobindo Pharma Limited
Substance NameDIDANOSINE
Active Ingredient Strength125 mg/1
Pharm ClassesHuman Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65862-310-05

500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-310-05)
Marketing Start Date2008-09-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-310-39 [65862031039]

Didanosine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090094
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-01
Marketing End Date2012-01-13

NDC 65862-310-30 [65862031030]

Didanosine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090094
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-09-24

NDC 65862-310-14 [65862031014]

Didanosine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090094
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-09-24

NDC 65862-310-05 [65862031005]

Didanosine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090094
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-09-24

Drug Details

Active Ingredients

IngredientStrength
DIDANOSINE125 mg/1

NDC Crossover Matching brand name "Didanosine" or generic name "Didanosine"

NDCBrand NameGeneric Name
0555-0588DidanosineDidanosine
0555-0589DidanosineDidanosine
0555-0590DidanosineDidanosine
53808-0236DidanosineDidanosine
53808-0353DidanosineDidanosine
65862-310DidanosineDidanosine
65862-311DidanosineDidanosine
65862-312DidanosineDidanosine
65862-313DidanosineDidanosine
0087-6632VIDEXdidanosine
0087-6633VIDEXdidanosine
0087-6671VIDEX ECdidanosine
0087-6672VIDEX ECdidanosine
0087-6673VIDEX ECdidanosine
0087-6674VIDEX ECdidanosine
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.