NDC 35356-634

FENTANYL

Fentanyl

FENTANYL is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Quality Care Products, Llc. The primary component is Fentanyl.

Product ID35356-634_0208a5a4-7ed4-4fe4-bf9f-5d205906721e
NDC35356-634
Product TypeHuman Prescription Drug
Proprietary NameFENTANYL
Generic NameFentanyl
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2005-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA076258
Labeler NameQuality Care Products, LLC
Substance NameFENTANYL
Active Ingredient Strength75 ug/h
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 35356-634-05

5 h in 1 CARTON (35356-634-05)
Marketing Start Date2015-02-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-634-05 [35356063405]

FENTANYL PATCH
Marketing CategoryANDA
Application NumberANDA076258
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-01-31
Marketing End Date2019-10-22

Drug Details

Active Ingredients

IngredientStrength
FENTANYL87.5 ug/h

OpenFDA Data

SPL SET ID:d287d93b-a764-4682-bcdb-958112d26473
Manufacturer
UNII

Pharmacological Class

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

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

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