NDC 21695-761

Nystatin

Nystatin

Nystatin is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Nystatin.

Product ID21695-761_fb98a6b8-da0c-40f4-9e53-487b541865b5
NDC21695-761
Product TypeHuman Prescription Drug
Proprietary NameNystatin
Generic NameNystatin
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date1993-01-29
Marketing CategoryANDA / ANDA
Application NumberANDA064022
Labeler NameRebel Distributors Corp
Substance NameNYSTATIN
Active Ingredient Strength100000 mg/g
Pharm ClassesPolyene Antifungal [EPC],Polyenes [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-761-15

1 TUBE in 1 CARTON (21695-761-15) > 15 g in 1 TUBE
Marketing Start Date1993-01-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-761-30 [21695076130]

Nystatin CREAM
Marketing CategoryANDA
Application NumberANDA064022
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1993-01-29
Inactivation Date2019-09-24

NDC 21695-761-15 [21695076115]

Nystatin CREAM
Marketing CategoryANDA
Application NumberANDA064022
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1993-01-29
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
NYSTATIN100000 mg/g

OpenFDA Data

SPL SET ID:fb98a6b8-da0c-40f4-9e53-487b541865b5
Manufacturer
UNII

Pharmacological Class

  • Polyene Antifungal [EPC]
  • Polyenes [CS]

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

NDCBrand NameGeneric Name
0093-0983NystatinNystatin
0121-0810NystatinNYSTATIN
0121-0868NystatinNYSTATIN
0121-4785NystatinNystatin
0121-4810NystatinNYSTATIN
0168-0007Nystatinnystatin
0168-0037nystatinnystatin
0168-0054nystatinnystatin
0374-5160NystatinNystatin Ointment
0472-0163NystatinNystatin
0472-0166NystatinNystatin
0603-1481NystatinNystatin
0603-7818Nystatinnystatin
0713-0678NystatinNystatin Cream
0713-0686NystatinNystatin Ointment
0904-6456NystatinNystatin
0904-7276NystatinNYSTATIN
13668-534NystatinNystatin
13668-595NystatinNystatin
68071-4293NystatinNystatin
68151-1487NystatinNystatin
68094-599NystatinNystatin
68308-152NystatinNystatin
68258-3046NystatinNystatin
68382-333NystatinNystatin
68382-370NystatinNystatin
68788-0178NystatinNystatin
68788-7366NystatinNystatin
68788-6792NystatinNystatin
68788-9516NystatinNystatin
68788-9247nystatinnystatin
68788-9072NystatinNystatin
69315-306NYSTATINNYSTATIN
70166-331NystatinNystatin
70518-1305NystatinNystatin
70771-1357NystatinNystatin
71205-106NystatinNystatin
76413-167NystatinNystatin
76413-119nystatinnystatin
76519-1007NystatinNystatin
16714-769NystatinNystatin
17856-0538NystatinNystatin
17856-0037NystatinNystatin
21695-643NystatinNystatin
21695-761NystatinNystatin
23155-051NystatinNystatin
33261-896NystatinNystatin
39822-3015NystatinNystatin
42254-284NystatinNystatin
42254-303NystatinNystatin

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.