NDC 0378-1300

Lithium Carbonate

Lithium Carbonate

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

Product ID0378-1300_4dea5284-2539-43e3-8002-fed27008f189
NDC0378-1300
Product TypeHuman Prescription Drug
Proprietary NameLithium Carbonate
Generic NameLithium Carbonate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-07-02
Marketing CategoryANDA / ANDA
Application NumberANDA202288
Labeler NameMylan Pharmaceuticals Inc.
Substance NameLITHIUM CARBONATE
Active Ingredient Strength300 mg/1
Pharm ClassesMood Stabilizer [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-1300-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1300-01)
Marketing Start Date2012-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1300-05 [00378130005]

Lithium Carbonate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202288
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-02

NDC 0378-1300-01 [00378130001]

Lithium Carbonate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202288
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-02

Drug Details

Active Ingredients

IngredientStrength
LITHIUM CARBONATE300 mg/1

OpenFDA Data

SPL SET ID:785a0327-998b-4154-9461-b72cb78e2739
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197891
  • UPC Code
  • 0303781300018
  • Pharmacological Class

    • Mood Stabilizer [EPC]

    NDC Crossover Matching brand name "Lithium Carbonate" or generic name "Lithium Carbonate"

    NDCBrand NameGeneric Name
    0054-0020Lithium CarbonateLithium Carbonate
    0054-0021Lithium CarbonateLithium Carbonate
    0054-2526Lithium CarbonateLithium Carbonate
    0054-2527Lithium CarbonateLithium Carbonate
    0054-2531Lithium CarbonateLithium Carbonate
    0054-4527Lithium CarbonateLithium Carbonate
    0054-8526Lithium CarbonateLithium Carbonate
    67544-946Lithium CarbonateLithium Carbonate
    68071-2186Lithium CarbonateLithium Carbonate
    68084-640Lithium CarbonateLithium Carbonate
    68084-655Lithium CarbonateLithium Carbonate
    68151-0639Lithium CarbonateLithium Carbonate
    68151-0245Lithium CarbonateLithium Carbonate
    68462-221Lithium CarbonateLithium Carbonate
    68462-220Lithium CarbonateLithium Carbonate
    68462-222Lithium CarbonateLithium Carbonate
    68462-223Lithium CarbonateLithium Carbonate
    68788-7164Lithium CarbonateLithium Carbonate
    0054-8528Lithium CarbonateLithium Carbonate
    0054-8531Lithium CarbonateLithium Carbonate
    0054-8527Lithium CarbonateLithium Carbonate
    70518-0150Lithium CarbonateLithium Carbonate
    70518-0360Lithium CarbonateLithium Carbonate
    70518-0377Lithium CarbonateLithium Carbonate
    70518-0629Lithium CarbonateLithium Carbonate
    70518-0437Lithium CarbonateLithium Carbonate
    70518-0668Lithium CarbonateLithium Carbonate
    70518-1434Lithium CarbonateLithium Carbonate
    70518-0608Lithium CarbonateLithium Carbonate
    70518-0904Lithium CarbonateLithium Carbonate
    70518-1481Lithium CarbonateLithium Carbonate
    70518-1753Lithium CarbonateLithium Carbonate
    70518-1567Lithium CarbonateLithium Carbonate
    71205-238Lithium CarbonateLithium Carbonate
    0615-1311Lithium CarbonateLithium Carbonate
    71335-0120Lithium CarbonateLithium Carbonate
    0615-2304Lithium CarbonateLithium Carbonate
    71335-1006Lithium CarbonateLithium Carbonate
    0615-5593Lithium CarbonateLithium Carbonate
    0904-6136Lithium CarbonateLithium Carbonate
    0904-6205Lithium CarbonateLithium Carbonate
    23155-293Lithium carbonateLithium carbonate
    31722-546Lithium CarbonateLithium Carbonate
    31722-545Lithium CarbonateLithium Carbonate
    33261-852Lithium CarbonateLithium Carbonate
    31722-544Lithium CarbonateLithium Carbonate
    0143-1300Lithium CarbonateLithium Carbonate
    0143-1277Lithium CarbonateLithium Carbonate
    43063-901Lithium CarbonateLithium Carbonate
    46708-148Lithium CarbonateLithium Carbonate

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