NDC 70529-048

Protherix

Triamcinolone Acetonide

Protherix is a Intra-articular; Intramuscular Injection, Suspension in the Human Prescription Drug category. It is labeled and distributed by It3 Medical Llc. The primary component is Triamcinolone Acetonide.

Product ID70529-048_7b8ac8f3-458c-45d6-baee-3f5246310b5e
NDC70529-048
Product TypeHuman Prescription Drug
Proprietary NameProtherix
Generic NameTriamcinolone Acetonide
Dosage FormInjection, Suspension
Route of AdministrationINTRA-ARTICULAR; INTRAMUSCULAR
Marketing Start Date2018-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA207550
Labeler NameIT3 Medical LLC
Substance NameTRIAMCINOLONE ACETONIDE
Active Ingredient Strength40 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70529-048-01

1 VIAL in 1 PACKAGE (70529-048-01) > 1 mL in 1 VIAL
Marketing Start Date2018-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70529-048-03 [70529004803]

Protherix INJECTION, SUSPENSION
Marketing CategoryANDA
Application NumberANDA207550
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-01

NDC 70529-048-02 [70529004802]

Protherix INJECTION, SUSPENSION
Marketing CategoryANDA
Application NumberANDA207550
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-01

NDC 70529-048-01 [70529004801]

Protherix INJECTION, SUSPENSION
Marketing CategoryANDA
Application NumberANDA207550
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-01

Drug Details

Active Ingredients

IngredientStrength
TRIAMCINOLONE ACETONIDE40 mg/mL

OpenFDA Data

SPL SET ID:da9376f8-0133-46e4-af09-b84d43a829d1
Manufacturer
UNII

Pharmacological Class

  • Corticosteroid [EPC]
  • Corticosteroid Hormone Receptor Agonists [MoA]
  • Corticosteroid [EPC]
  • Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "Protherix" or generic name "Triamcinolone Acetonide"

NDCBrand NameGeneric Name
70529-048ProtherixProtherix
0363-0811Allergy NasalTriamcinolone acetonide
0113-7005basic care nasal allergyTriamcinolone acetonide
0113-0443Good Sense Nasal AllergyTriamcinolone acetonide
0003-0494KENALOG-10TRIAMCINOLONE ACETONIDE
0003-0293KENALOG-40TRIAMCINOLONE ACETONIDE
0003-0315KENALOG-80TRIAMCINOLONE ACETONIDE
0168-0002triamcinolone acetonidetriamcinolone acetonide
0168-0003triamcinolone acetonidetriamcinolone acetonide
0168-0004triamcinolone acetonidetriamcinolone acetonide
0168-0005Triamcinolone Acetonidetriamcinolone acetonide
0168-0006Triamcinolone Acetonidetriamcinolone acetonide
0168-0336triamcinolone acetonidetriamcinolone acetonide
0168-0337triamcinolone acetonidetriamcinolone acetonide
0440-0251Triamcinolone acetonideTriamcinolone acetonide
0440-0317Triamcinolone acetonideTriamcinolone acetonide
0440-0318Triamcinolone acetonideTriamcinolone acetonide
0603-7862Triamcinolone Acetonidetriamcinolone acetonide
0603-7864Triamcinolone AcetonideTriamcinolone Acetonide
0316-0165TRIDERMTriamcinolone Acetonide
0316-0170TRIDERMTriamcinolone Acetonide
0316-0175TRIDERMTriamcinolone Acetonide
0065-0543TRIESENCEtriamcinolone acetonide
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