NDC 0406-9921

TOFRANIL

Imipramine Hydrochloride

TOFRANIL is a Oral Tablet, Sugar Coated in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Imipramine Hydrochloride.

Product ID0406-9921_0a39151b-1dc1-42c3-b5e4-b9240ff33955
NDC0406-9921
Product TypeHuman Prescription Drug
Proprietary NameTOFRANIL
Generic NameImipramine Hydrochloride
Dosage FormTablet, Sugar Coated
Route of AdministrationORAL
Marketing Start Date1984-05-22
Marketing CategoryANDA / ANDA
Application NumberANDA087846
Labeler NameSpecGx LLC
Substance NameIMIPRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0406-9921-01

100 TABLET, SUGAR COATED in 1 BOTTLE (0406-9921-01)
Marketing Start Date1984-05-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-9921-01 [00406992101]

TOFRANIL TABLET, SUGAR COATED
Marketing CategoryANDA
Application NumberANDA087846
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-05-22

NDC 0406-9921-03 [00406992103]

TOFRANIL TABLET, SUGAR COATED
Marketing CategoryANDA
Application NumberANDA087846
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1984-05-22

Drug Details

Active Ingredients

IngredientStrength
IMIPRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:1827a5aa-733a-49d9-89d9-48ea0367b230
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835570
  • 835593
  • 835564
  • 835596
  • 835566
  • 835568
  • UPC Code
  • 0304069922038
  • 0304069920034
  • 0304069921031
  • Pharmacological Class

    • Tricyclic Antidepressant [EPC]

    NDC Crossover Matching brand name "TOFRANIL" or generic name "Imipramine Hydrochloride"

    NDCBrand NameGeneric Name
    0406-9920TOFRANILimipramine hydrochloride
    0406-9921TOFRANILimipramine hydrochloride
    0406-9922TOFRANILimipramine hydrochloride
    69874-992TofranilTofranil
    0781-1762Imipramine HydrochlorideImipramine Hydrochloride
    0781-1764Imipramine HydrochlorideImipramine Hydrochloride
    0781-1766Imipramine HydrochlorideImipramine Hydrochloride
    42291-345Imipramine HydrochlorideImipramine Hydrochloride
    42291-346Imipramine HydrochlorideImipramine Hydrochloride
    42291-347Imipramine HydrochlorideImipramine Hydrochloride
    49884-054Imipramine HydrochlorideImipramine Hydrochloride
    49884-055Imipramine HydrochlorideImipramine Hydrochloride
    49884-056Imipramine HydrochlorideImipramine Hydrochloride
    50090-0034Imipramine HydrochlorideImipramine Hydrochloride
    50090-0035Imipramine HydrochlorideImipramine Hydrochloride
    50090-3148Imipramine HydrochlorideImipramine Hydrochloride
    50436-2022Imipramine HydrochlorideImipramine Hydrochloride
    51655-455IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE
    53489-330Imipramine HydrochlorideImipramine Hydrochloride
    53489-331Imipramine HydrochlorideImipramine Hydrochloride
    53489-332Imipramine HydrochlorideImipramine Hydrochloride
    54738-912Imipramine HydrochlorideImipramine Hydrochloride
    54738-913Imipramine HydrochlorideImipramine Hydrochloride
    54738-914Imipramine HydrochlorideImipramine Hydrochloride
    55289-144Imipramine HydrochlorideImipramine Hydrochloride

    Trademark Results [TOFRANIL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TOFRANIL
    TOFRANIL
    87543724 5406873 Live/Registered
    SPECGX LLC
    2017-07-26
    TOFRANIL
    TOFRANIL
    86949105 not registered Dead/Abandoned
    Integrated Pharma Solutions
    2016-03-22
    TOFRANIL
    TOFRANIL
    72045471 0672089 Dead/Expired
    GEIGY CHEMICAL CORPORATION
    1958-02-07

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.