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 5 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lithium CarbonateLITHIUM CARBONATEAmerican Health Packaging5ce5ebd2-f1b5-4c04-a7de-56a1b7eb81972025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
Natural Relief Arthritis TherapyAPIS MELLIFERA, SALICYLIC ACID, RUTA GRAVEOLENS, TOXICODENDRON PUBESCEN, LITHIUM CARBONATE, BRYONIA ALBA, CALCIUM FLUORIDETRP Company436f7af7-859e-f7af-e063-6294a90af5082025-11-12WarningsExact identifier
unii: 2BMD2GNA4V
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
Lithium CarbonateLITHIUM CARBONATEPD-Rx Pharmaceuticals, Inc.039f188c-413a-6e64-e063-6294a90a29722025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
Lithium CarbonateLITHIUM CARBONATEPD-Rx Pharmaceuticals, Inc.edfceebd-a3e4-4905-bffe-cdc0b948dcd22025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076691
rxcui: 197892
unii: 2BMD2GNA4V
Lithium CarbonateLITHIUM CARBONATEPD-Rx Pharmaceuticals, Inc.16ebe1f9-501d-468b-a37d-f6a46f8f32d12025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
Lithium CarbonateLITHIUM CARBONATEPD-Rx Pharmaceuticals, Inc.c4973d87-d014-42f4-ba13-ae628ca1a4512025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
Lithium carbonateLITHIUM CARBONATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.074e3c3b-3a36-4c66-b0a7-e19f9aac85482025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
Lithium CarbonateLITHIUM CARBONATECoupler LLC3dfeeb11-a096-ae17-e063-6294a90a9aae2025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2BMD2GNA4V
Rena-ChordHOMEOPATHIC LIQUIDEnergetix Corporation4071f90a-8a28-4338-810b-c9b18cf32f872025-07-15WarningsExact identifier
unii: 2BMD2GNA4V
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: 2BMD2GNA4V
Heart Small Intestine Meridian OpenerARSENICUM ALBUM, AURUM METALLICUM, BELLADONNA, CACTUS GRANDIFLORUS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, KALI CARBONICUM, LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), PYROGENIUM, SPIGELIA ANTHELMIADeseret Biologicals, Inc.5b693acf-acfd-42d9-b7ac-7c7b5923ed612025-05-27WarningsExact identifier
unii: 2BMD2GNA4V
MetDetoxALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, TANTALUM METALLICUM, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM,Dr. Donna Restivo DC89ce5e89-c592-445e-92f9-365133005fb32025-05-23WarningsExact identifier
unii: 2BMD2GNA4V
NeurotoxAGARICUS MUSCARIUS, COCCUS CACTI, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, CHROMIUM, COBALTUM METALLICUM, CUPRUM METALLICUM, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, EUROPIUM METALLICUM, FERRUM METALLICUM, GADOLINIUM METALLICUM, GERMANIUM SESQUIOXIDE,BioActive Nutritional, Inc.07a457c0-df0d-468a-b0d8-84c739c17b702025-05-19WarningsExact identifier
unii: 2BMD2GNA4V
Lithium CarbonateLITHIUM CARBONATERising Pharma Holdings, Inc.5e18d105-662d-4729-aa81-00be7472adde2025-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197892
unii: 2BMD2GNA4V
Heart Small Intestine Meridian OpenerARSENICUM ALBUM, AURUM METALLICUM, CACTUS GRANDIFLORUS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, KALI CARBONICUM, LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), PYROGENIUM, SPIGELIA ANTHELMIADeseret Biologicals, Inc.0f398c70-455c-48be-9af3-3eccc96d99a12025-05-06WarningsExact identifier
unii: 2BMD2GNA4V

Reported adverse events (FAERS/openFDA)#

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