NDC 69784-905

Orphenadrine Citrate

Orphenadrine Citrate

Orphenadrine Citrate is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Woodward Pharma Services Llc. The primary component is Orphenadrine Citrate.

Product ID69784-905_60b2e28d-8356-60dd-e053-2a91aa0a3c5a
NDC69784-905
Product TypeHuman Prescription Drug
Proprietary NameOrphenadrine Citrate
Generic NameOrphenadrine Citrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-05-26
Marketing CategoryANDA / ANDA
Application NumberANDA040249
Labeler NameWoodward Pharma Services LLC
Substance NameORPHENADRINE CITRATE
Active Ingredient Strength100 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 69784-905-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69784-905-01)
Marketing Start Date2017-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69784-905-01 [69784090501]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040249
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ORPHENADRINE CITRATE100 mg/1

OpenFDA Data

SPL SET ID:5b317bfd-633d-0ce1-e053-2991aa0aa4c3
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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