Lithium Carbonate

Product NDC
46708-305
11-digit product format
467080305
Labeler code
46708
Product ID
46708-305_f4a09dd5-000a-48d2-9681-d5bc360164f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA079159
Marketing category
ANDA
Marketing start
2016-12-27
Substance
LITHIUM CARBONATE
Active strength
600 mg/1
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
46708-305_f4a09dd5-000a-48d2-9681-d5bc360164f1
SPL ID
f4a09dd5-000a-48d2-9681-d5bc360164f1
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Lithium Carbonate
Generic name
Lithium Carbonate
Dosage form
CAPSULE
Route
ORAL
Marketing start
2016-12-27
Marketing category
ANDA
Application number
ANDA079159
Pharmacologic classes
Mood Stabilizer [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
LITHIUM CARBONATE600 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii2BMD2GNA4V
Rxcui197889, 197893, 311355
Spl Set Idd1800f34-3d67-4b2f-874e-8639b125d853
Manufacturer NameAlembic Pharmaceuticals Limited

openFDA Package Details

Package NDCDescriptionMarketing startSample
46708-305-3030 CAPSULE in 1 BOTTLE (46708-305-30)2016-12-27No
46708-305-31100 CAPSULE in 1 BOTTLE (46708-305-31)2016-12-27No
46708-305-71500 CAPSULE in 1 BOTTLE (46708-305-71)2016-12-27No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
2BMD2GNA4VLITHIUM CARBONATE554-13-2LITHIUM CARBONATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-305-304670803053030 CAPSULE in 1 BOTTLE (46708-305-30) 30 capsule2016-12-27NoNoHistorical
46708-305-3146708030531100 CAPSULE in 1 BOTTLE (46708-305-31) 100 capsule2016-12-27NoNoHistorical
46708-305-7146708030571500 CAPSULE in 1 BOTTLE (46708-305-71) 500 capsule2016-12-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Lithium Carbonate Capsules USP Rx OnlyAlembic Pharmaceuticals Limited2023-01-27Human Prescription Drug Label3