NDC 0409-1254

DEMEROL

Meperidine Hydrochloride

DEMEROL is a Intramuscular; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Meperidine Hydrochloride.

Product ID0409-1254_25a09d2b-bec0-4b0d-85ed-9c7ccc67af4f
NDC0409-1254
Product TypeHuman Prescription Drug
Proprietary NameDEMEROL
Generic NameMeperidine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2006-03-22
Marketing CategoryNDA / NDA
Application NumberNDA021171
Labeler NameHospira, Inc.
Substance NameMEPERIDINE HYDROCHLORIDE
Active Ingredient Strength75 mg/1.5mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0409-1254-01

25 AMPULE in 1 CARTON (0409-1254-01) > 1.5 mL in 1 AMPULE (0409-1254-11)
Marketing Start Date2006-03-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-1254-01 [00409125401]

DEMEROL INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021171
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-03-22

NDC 0409-1254-11 [00409125411]

DEMEROL INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021171
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-12-16

Drug Details

Active Ingredients

IngredientStrength
MEPERIDINE HYDROCHLORIDE75 mg/1.5mL

OpenFDA Data

SPL SET ID:b31d1308-28c3-43f4-e0a6-2f3ed76b8975
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861494
  • 861459
  • 861493
  • 861473
  • 860792
  • 1242106
  • 1665687
  • 1665685
  • 1665702
  • 1665700
  • 1665701
  • 1242503
  • 861529
  • 861520
  • 861522
  • 861617
  • 861463
  • 1665690
  • 1665691
  • 1665697
  • 1665698
  • 1665699
  • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "DEMEROL" or generic name "Meperidine Hydrochloride"

    NDCBrand NameGeneric Name
    0409-1176DEMEROLMEPERIDINE HYDROCHLORIDE
    0409-1178DEMEROLMEPERIDINE HYDROCHLORIDE
    0409-1179DEMEROLMEPERIDINE HYDROCHLORIDE
    30698-335DemerolDemerol
    30698-337DemerolDemerol
    0409-1254DEMEROLDEMEROL
    0409-1256DEMEROLDEMEROL
    0409-1180DEMEROLDEMEROL
    0409-1253DEMEROLDEMEROL
    0409-1203DEMEROLDEMEROL
    0409-1255DEMEROLDEMEROL
    0409-1181DEMEROLDEMEROL
    0409-1201DEMEROLDEMEROL
    0054-3545Meperidine HydrochlorideMeperidine Hydrochloride
    0054-4595Meperidine HydrochlorideMeperidine Hydrochloride
    0054-4596Meperidine HydrochlorideMeperidine Hydrochloride
    0054-8595Meperidine HydrochlorideMeperidine Hydrochloride

    Trademark Results [DEMEROL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DEMEROL
    DEMEROL
    71431897 0381130 Live/Registered
    Alba Pharmaceutical Company, Inc.
    1940-05-14

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