NDC 43063-407

ORPHENADRINE CITRATE

Orphenadrine Citrate

ORPHENADRINE CITRATE is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Orphenadrine Citrate.

Product ID43063-407_7f6fec33-cdf9-6488-e053-2991aa0adbe8
NDC43063-407
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 NamePD-Rx Pharmaceuticals, Inc.
Substance NameORPHENADRINE CITRATE
Active Ingredient Strength100 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43063-407-14

14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-14)
Marketing Start Date2013-06-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-407-20 [43063040720]

ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-06-18

NDC 43063-407-30 [43063040730]

ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-06-18

NDC 43063-407-14 [43063040714]

ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-06-18

NDC 43063-407-60 [43063040760]

ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-06-18

Drug Details

Active Ingredients

IngredientStrength
ORPHENADRINE CITRATE100 mg/1

OpenFDA Data

SPL SET ID:87d78229-f022-4b42-a03c-4e6a985c714f
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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