FDA.reportPublic FDA data

NDC 68084-655-11 - Lithium Carbonate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68084-655
Requested NDC
68084-655-11
Package NDCs from labels
68084-655-11, 68084-655-01
Manufacturer
American Health Packaging
Effective date
2025-11-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lithium Carbonate - American Health PackagingAmerican Health Packaging2025-11-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-655-01Lithium Carbonate100 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE1008
68084-655-11Lithium Carbonate1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-655LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20240417_d276da3c-9952-4674-a54d-b1258df71b8a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-655-01EA - Each68084-65536833190-962b-4aeb-bda1-b41e76928cc012014-02-04
68084-655-11EA - Each68084-655d93fd534-3360-4b49-9601-d75577a2eb4312014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ELITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 9 · 179 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
LITHOBIDLITHIUM CARBONATEANI Pharmaceuticals, Inc.f7f5b69a-c2a1-4586-a189-1475d41387c02026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
Lithium CarbonateLITHIUM CARBONATEHikma Pharmaceuticals USA Inc.b839ff4b-f62d-41ab-a823-550a756d58ec2026-08-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: 2BMD2GNA4V
lithium carbonateLITHIUM CARBONATECoupler LLC582697c1-063f-366f-e063-6294a90a8d1b2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.803eab29-0d0a-4df0-b504-bcd85ec01ead2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.1c320bff-b4d5-42f2-b2b5-238564fe95892026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.05312159-3d8a-45e0-99cb-b83a7b200cd32026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.c84cce95-cfcb-4426-aac6-d2f48f946ada2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.611b0ea2-6378-4c8f-953d-87f6b35b06342026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: 2BMD2GNA4V
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.aa900d48-a99f-4309-ba29-ecc8941627502026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076691
rxcui: 197892
unii: 2BMD2GNA4V
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.453721b5-b1f5-4161-8e01-8b4803151dc52026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.