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 ID: 0378-1300_4dea5284-2539-43e3-8002-fed27008f189
• NDC: 0378-1300
• Product Type: Human Prescription Drug
• Proprietary Name: Lithium Carbonate
• Generic Name: Lithium Carbonate
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2012-07-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202288
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: LITHIUM CARBONATE
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Mood Stabilizer [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0378-1300-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1300-01)

• Marketing Start Date: 2012-07-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-1300-05 [00378130005]

Lithium Carbonate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA202288
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-07-02

NDC 0378-1300-01 [00378130001]

Lithium Carbonate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA202288
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-07-02

Drug Details

Active Ingredients

Ingredient	Strength
LITHIUM CARBONATE	300 mg/1

OpenFDA Data

• SPL SET ID: 785a0327-998b-4154-9461-b72cb78e2739
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 2BMD2GNA4V
• 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"

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