NDC 63629-4974

FENTANYL

Fentanyl

FENTANYL is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Fentanyl.

Product ID63629-4974_3479b396-46e8-4614-8bd0-979a663dd745
NDC63629-4974
Product TypeHuman Prescription Drug
Proprietary NameFENTANYL
Generic NameFentanyl
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2013-04-04
Marketing CategoryANDA / ANDA
Application NumberANDA077449
Labeler NameBryant Ranch Prepack
Substance NameFENTANYL
Active Ingredient Strength25 ug/h
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63629-4974-1

1 h in 1 BOTTLE (63629-4974-1)
Marketing Start Date2013-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-4974-1 [63629497401]

FENTANYL PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077449
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-30
Marketing End Date2018-03-30

NDC 63629-4974-2 [63629497402]

FENTANYL PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077449
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-30
Marketing End Date2018-03-30

Drug Details

NDC Crossover Matching brand name "FENTANYL" or generic name "Fentanyl"

NDCBrand NameGeneric Name
0378-9119FENTANYLFENTANYL
0378-9121FENTANYLFENTANYL
0378-9122FENTANYLFENTANYL
0378-9123FENTANYLFENTANYL
0378-9124FENTANYLFENTANYL
0378-9125FENTANYLFENTANYL
0378-9126FENTANYLFENTANYL
0378-9127FENTANYLFENTANYL
0591-3198FentanylFentanyl
0591-3212FentanylFentanyl
0591-3213FentanylFentanyl
0591-3214FentanylFentanyl
0781-7240FentanylFentanyl
0781-7241FentanylFentanyl
0781-7242FentanylFentanyl
0781-7243FentanylFentanyl
0781-7244FentanylFentanyl
68258-3023FentanylFentanyl
68258-3040FentanylFentanyl
68258-3024FentanylFentanyl
68258-3025FentanylFentanyl
71335-0376FENTANYLFENTANYL
71335-0649FentanylFentanyl
71335-0556FentanylFentanyl
71335-0604FentanylFentanyl
35356-633FENTANYLFENTANYL
35356-635FentanylFentanyl
35356-062FentanylFentanyl
35356-632FENTANYLFENTANYL
35356-634FENTANYLFENTANYL
49884-763FentanylFentanyl
49884-762FentanylFentanyl
49884-764FentanylFentanyl
49884-761FentanylFentanyl
49999-834FentanylFentanyl
49999-832FentanylFentanyl
49999-833FentanylFentanyl
49999-831FentanylFentanyl
51862-317FentanylFentanyl
51862-314FentanylFentanyl
51862-316FentanylFentanyl
51862-315FentanylFentanyl
52959-585FentanylFentanyl
52959-658FentanylFentanyl
55700-402FENTANYLFENTANYL
60505-7081FENTANYLFENTANYL
60505-7086FENTANYLFENTANYL
60505-7082FENTANYLFENTANYL
60505-7009FENTANYLFENTANYL
60505-7014FENTANYLFENTANYL

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