NDC 0378-0541

Cimetidine

Cimetidine

Cimetidine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Cimetidine.

Product ID0378-0541_713ee26b-df22-40bb-b0bb-6a2d47f16ce0
NDC0378-0541
Product TypeHuman Prescription Drug
Proprietary NameCimetidine
Generic NameCimetidine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1994-05-17
Marketing CategoryANDA / ANDA
Application NumberANDA074246
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCIMETIDINE
Active Ingredient Strength800 mg/1
Pharm ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-0541-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0541-01)
Marketing Start Date1994-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0541-01 [00378054101]

Cimetidine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074246
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1994-05-17

Drug Details

Active Ingredients

IngredientStrength
CIMETIDINE800 mg/1

OpenFDA Data

SPL SET ID:06c0a509-026f-44e0-9975-a94a8de51d43
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197508
  • 197505
  • 197506
  • 197507
  • Pharmacological Class

    • Histamine H2 Receptor Antagonists [MoA]
    • Histamine-2 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "Cimetidine" or generic name "Cimetidine"

    NDCBrand NameGeneric Name
    0093-8192CimetidineCimetidine
    0093-8204CimetidineCimetidine
    0093-8305CimetidineCimetidine
    0121-0649CimetidineCimetidine Hydrochloride
    0121-1298CimetidineCimetidine Hydrochloride
    0363-0022cimetidineCimetidine
    0378-0053Cimetidinecimetidine
    0378-0317Cimetidinecimetidine
    0378-0372Cimetidinecimetidine
    0378-0541Cimetidinecimetidine
    0440-1282CIMETIDINECIMETIDINE
    10544-626CimetidineCimetidine
    10544-627CimetidineCimetidine
    33261-024CimetidineCimetidine
    68151-1742CimetidineCimetidine
    68151-1497CimetidineCimetidine
    68151-2899CimetidineCimetidine
    68788-9064CimetidineCimetidine
    42291-217CimetidineCimetidine
    42291-218CimetidineCimetidine
    50090-0500CimetidineCimetidine
    55289-581CimetidineCimetidine
    63187-333CimetidineCimetidine
    63629-1783CimetidineCimetidine
    63629-1497CimetidineCimetidine
    66267-057CimetidineCimetidine
    66336-945CimetidineCimetidine
    50090-3574CimetidineCimetidine
    50090-0499CimetidineCimetidine
    70518-2809CimetidineCimetidine
    30142-323Acid ReducerCimetidine
    24385-111Good Neighbor Pharmacy Heartburn ReliefCimetidine
    0113-0022Good Sense Heartburn ReliefCimetidine
    36800-022TopCare Heartburn ReliefCimetidine

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