NDC 63629-1564

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 ID63629-1564_2b14b457-9a6b-48c6-b83a-79b526eac0bd
NDC63629-1564
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 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 Through2019-12-31

Packaging

NDC 63629-1564-0

56 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-0)
Marketing Start Date2006-09-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-1564-1 [63629156401]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-06-19
Inactivation Date2020-01-31

NDC 63629-1564-6 [63629156406]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-06-19
Inactivation Date2020-01-31

NDC 63629-1564-2 [63629156402]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-06-19
Inactivation Date2020-01-31

NDC 63629-1564-4 [63629156404]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-06-19
Inactivation Date2020-01-31

NDC 63629-1564-3 [63629156403]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-06-19
Inactivation Date2020-01-31

NDC 63629-1564-8 [63629156408]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-06-19
Inactivation Date2020-01-31

NDC 63629-1564-9 [63629156409]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-06-19
Inactivation Date2020-01-31

NDC 63629-1564-5 [63629156405]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-06-19
Inactivation Date2020-01-31

NDC 63629-1564-0 [63629156400]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-06-19
Inactivation Date2020-01-31

NDC 63629-1564-7 [63629156407]

Orphenadrine Citrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-06-19
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ORPHENADRINE CITRATE100 mg/1

OpenFDA Data

SPL SET ID:8408d24e-3948-548d-bb12-b1edf0c05e12
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.