NDC 71335-0117

Orphenadrine Citrate

Orphenadrine Citrate

Orphenadrine Citrate is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Orphenadrine Citrate.

Product ID71335-0117_30996f91-5b58-431b-94f5-842db03be6f3
NDC71335-0117
Product TypeHuman Prescription Drug
Proprietary NameOrphenadrine Citrate
Generic NameOrphenadrine Citrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2000-02-15
Marketing CategoryANDA / ANDA
Application NumberANDA040327
Labeler NameBryant Ranch Prepack
Substance NameORPHENADRINE CITRATE
Active Ingredient Strength100 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-0117-0

56 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0117-0)
Marketing Start Date2022-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0117-9 [71335011709]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-02-15

NDC 71335-0117-0 [71335011700]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-02-15

NDC 71335-0117-3 [71335011703]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-02-15

NDC 71335-0117-5 [71335011705]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-02-15

NDC 71335-0117-4 [71335011704]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-02-15

NDC 71335-0117-6 [71335011706]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-02-15

NDC 71335-0117-2 [71335011702]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-02-15

NDC 71335-0117-7 [71335011707]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-02-15

NDC 71335-0117-1 [71335011701]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-02-15

NDC 71335-0117-8 [71335011708]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-02-15

Drug Details

Active Ingredients

IngredientStrength
ORPHENADRINE CITRATE100 mg/1

OpenFDA Data

SPL SET ID:d5dc7cee-4415-4f4c-8b46-f173f050cfbb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 994521

    • Pharmacological Class

    • Centrally-mediated Muscle Relaxation [PE]
    • Muscle Relaxant [EPC]

    NDC Crossover Matching brand name "Orphenadrine Citrate" or generic name "Orphenadrine Citrate"

    NDCBrand NameGeneric Name
    0115-2011Orphenadrine CitrateORPHENADRINE CITRATE
    0185-0022Orphenadrine CitrateOrphenadrine Citrate
    0591-3222Orphenadrine CitrateOrphenadrine Citrate
    0641-6182Orphenadrine citrateOrphenadrine citrate
    10544-283Orphenadrine CitrateOrphenadrine Citrate
    17478-538Orphenadrine CitrateOrphenadrine Citrate
    21695-099Orphenadrine CitrateOrphenadrine Citrate
    25021-651Orphenadrine Citrateorphenadrine citrate
    33261-088Orphenadrine CitrateOrphenadrine Citrate
    33358-274Orphenadrine CitrateOrphenadrine Citrate
    43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATE
    43386-480ORPHENADRINE CITRATEORPHENADRINE CITRATE
    45865-363Orphenadrine CitrateOrphenadrine Citrate
    49999-046Orphenadrine CitrateOrphenadrine Citrate
    50090-0169Orphenadrine CitrateORPHENADRINE CITRATE
    50090-2438Orphenadrine CitrateOrphenadrine Citrate
    50090-3150Orphenadrine CitrateORPHENADRINE CITRATE
    50436-7601Orphenadrine CitrateORPHENADRINE CITRATE
    52959-527Orphenadrine CitrateORPHENADRINE CITRATE
    53002-5430ORPHENADRINE CITRATEORPHENADRINE CITRATE
    60760-810Orphenadrine CitrateOrphenadrine Citrate
    61919-177Orphenadrine CitrateOrphenadrine Citrate
    61919-507ORPHENADRINE CITRATEORPHENADRINE CITRATE
    68084-820Orphenadrine CitrateOrphenadrine Citrate
    68151-1463Orphenadrine CitrateOrphenadrine Citrate
    68788-9138Orphenadrine CitrateOrphenadrine Citrate
    68788-9306Orphenadrine CitrateOrphenadrine Citrate
    68788-9150Orphenadrine CitrateOrphenadrine Citrate
    69784-905Orphenadrine CitrateOrphenadrine Citrate
    71335-0117Orphenadrine CitrateOrphenadrine Citrate
    63187-122Orphenadrine CitrateOrphenadrine Citrate
    63187-632Orphenadrine CitrateOrphenadrine Citrate
    63629-1564Orphenadrine CitrateOrphenadrine Citrate
    66336-554Orphenadrine CitrateOrphenadrine Citrate
    66267-158Orphenadrine CitrateOrphenadrine Citrate
    67296-0709Orphenadrine CitrateOrphenadrine Citrate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.