NDC 63187-122

Orphenadrine Citrate

Orphenadrine Citrate

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

Product ID63187-122_881465db-b843-4384-b7fa-73edadb4aa60
NDC63187-122
Product TypeHuman Prescription Drug
Proprietary NameOrphenadrine Citrate
Generic NameOrphenadrine Citrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date1998-06-19
Marketing CategoryANDA / ANDA
Application NumberANDA040284
Labeler NameProficient Rx LP
Substance NameORPHENADRINE CITRATE
Active Ingredient Strength100 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63187-122-20

20 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-20)
Marketing Start Date2015-02-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-122-02 [63187012202]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-12-31
Marketing End Date2015-01-01

NDC 63187-122-60 [63187012260]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-02

NDC 63187-122-30 [63187012230]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-02

NDC 63187-122-20 [63187012220]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-02-02

NDC 63187-122-90 [63187012290]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-02-02

Drug Details

Active Ingredients

IngredientStrength
ORPHENADRINE CITRATE100 mg/1

OpenFDA Data

SPL SET ID:cf620257-7497-44c1-9853-87f96d262fbd
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
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