NDC 61919-177

Orphenadrine Citrate

Orphenadrine Citrate

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

Product ID61919-177_26a62ccc-18fe-405c-e054-00144ff88e88
NDC61919-177
Product TypeHuman Prescription Drug
Proprietary NameOrphenadrine Citrate
Generic NameOrphenadrine Citrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA040284
Labeler NameDirect RX
Substance NameORPHENADRINE CITRATE
Active Ingredient Strength100 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-177-72

120 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-177-72)
Marketing Start Date2019-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-177-90 [61919017790]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-177-72 [61919017772]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-29

NDC 61919-177-30 [61919017730]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-177-60 [61919017760]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-177-20 [61919017720]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-11
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ORPHENADRINE CITRATE100 mg/1

OpenFDA Data

SPL SET ID:8a258480-2f47-4b62-850c-1beed383ba29
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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