FDA.reportPublic FDA data

NDC 70954-159-40 - Clorazepate Dipotassium

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
70954-159
Requested NDC
70954-159-40
Package NDCs from labels
70954-159-10, 70954-159-20, 70954-159-30, 70954-159-40, 70954-159-50
Manufacturer
ANI Pharmaceuticals, Inc. | Novitium Pharma LLC
Effective date
2025-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clorazepate Dipotassium - ANI Pharmaceuticals, Inc. | Novitium Pharma LLCANI Pharmaceuticals, Inc. | Novitium Pharma LLC2025-08-12Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-159-10Clorazepate Dipotassium100 in 1 BOTTLETABLET10013
70954-159-20Clorazepate Dipotassium500 in 1 BOTTLETABLET50013
70954-159-30Clorazepate Dipotassium30 in 1 BOTTLETABLET3013
70954-159-40Clorazepate Dipotassium1 in 1 BLISTER PACKTABLET113
70954-159-50Clorazepate Dipotassium30 in 1 BOX, UNIT-DOSETABLET3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-159CLORAZEPATE DIPOTASSIUM TABLET [ANI PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 5 package rows20250112_a4b80e69-b7c7-471a-8ce8-4e992808c669.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-159-10EA - Each70954-1594d201f37-b4a8-49b9-a0d4-427f95511aea12022-07-06
70954-159-30EA - Each70954-15966ddfa29-e746-4559-a6b5-94c2869fe13712023-09-05
70954-159-40EA - Each70954-159ef021671-4401-4255-978d-e5a694e8b1fc12025-07-08
70954-159-50EA - Each70954-159195dbf33-cf57-4b67-aabb-f74d7704ab0612025-07-08

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 46 of 63 · 1,247 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
COUGHTONEECHINACEA, LOBELIA INFLATA, ANTIMONIUM TARTARICUM, ARALIA RACEMOSA, DROSERA (ROTUNDIFOLIA), IPECACUANHA, KALI CARBONICUM, PHOSPHORUS, SPONGIA TOSTAEnergique, Inc.0d4514ca-fbe0-4139-8151-aad039ccf05a2024-01-23WarningsExact identifier
unii: BQN1B9B9HA
Potassium ChloridePOTASSIUM CHLORIDEAmerican Health Packaginga67f5ba7-ac23-4bdc-9563-cb7fd049a9512024-01-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma LLC69451c35-dd9a-4690-8d5e-4dcfa88376202024-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197465
rxcui: 197466
rxcui: 197464
unii: 63FN7G03XY
Sleep TightADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Dr. Donna Restivo DCb5955fbc-71f8-4fe0-9df0-42f337ab9c7d2024-01-18WarningsExact identifier
unii: ETJ7Z6XBU4
PNV-SelectVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDEAcella Pharmaceuticals, LLC9f4ce551-7a80-4ddb-a014-95c44b54a4202024-01-16Boxed warning, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Lung DrainageKALI MURIATICUM, CARBO VEGETABILIS, LUNG (SUIS), MYCOPLASMA PNEUMONIAE, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HAEMOPHILUS INFLUENZAE B, PNEUMOCOCCINUM, OXYGENIUM, ANTIMONIUM ARSENICICUM, CAMPHORA, CHELIDONIUM MAJUS, CHININUM MURIATICUM, CUPRUM METALLICUM, IPECACUANHA, LOBELIA PURPURESCENS, PHOSPHORUS, SENEGA OFFICINALIS, STANNUM METALLICUM, VERATRUM VIRIDEDeseret Biologicals, Inc.8fdb37fb-f3df-4dae-abb4-1f3a71c1c6832024-01-15WarningsExact identifier
unii: 660YQ98I10
Quflora PediatricVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDECarWin Pharmaceutical Associates, LLCb8e08798-d8bb-4616-996b-a2c07a5d730a2024-01-10Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
POTASSIUM CHLORIDEPOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.4d90d03d-7f0e-4d49-9e80-628dbc7165c02024-01-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.8ed8ea55-8b15-f718-e053-2a95a90a587a2024-01-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
TriStart DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, AND ICOSAPENTCarWin Pharmaceutical Associates, LLC92ccf7d4-4527-49f0-b890-1a11b5a100862024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
A05 HEAVY ANTITOXALLIUM CEPA, ALLIUM SATIVUM, ALUMINIUM METALLICUM, APIS MELLIFICA, ARGENTUM METALLICUM, AURUM METALLICUM, BELLADONNA, BERBERIS VULGARIS, CADMIUM METALLICUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, FAGUS SYLVATICA, FORMALINUM, FORMICUM ACIDUM, HYPERICUM PERFORATUM, ICHTHYOLUM, MERCURIUS CORROSIVUS, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PLUMBUM METALLICUM, SELENIUM METALLICUM, SILICEA, SOLIDAGO VIRGAUREA, STANNUM METALLICUM, THIOSINAMINUMApex Energetics Inc.b9bdc39e-8ebf-615c-e053-2a95a90afe1b2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: BQN1B9B9HA
B04 DIGESTIONALFALFA, ANTIMONIUM CRUDUM, AVENA SATIVA, BERBERIS VULGARIS, CAJUPUTUM, CARBO ANIMALIS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, FEL TAURI, GENTIANA LUTEA, GLYCYRRHIZA GLABRA, ILLICIUM ANISATUM, INDOLUM, KALI CARBONICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PANCREATINUM, PEPSINUM, RAPHANUS SATIVUS, RHAMNUS PURSHIANA, SKATOLUMApex Energetics Inc.bad8bfa1-a882-65b1-e053-2995a90a02f72024-01-08WarningsExact identifier
unii: BQN1B9B9HA
C08 CALCIUM METABOLISMABIES ALBA LEAFY TWIG, CALCAREA ACETICA, CALCAREA ARSENICICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA HYPOPHOSPHOROSA, CALCAREA IODATA, CALCAREA MURIATICA, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CALCAREA PICRATA, CALCAREA SULPHURICA, CALCULUS BOVIS, CALENDULA OFFICINALIS, CHOLESTERINUM, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUS, SILICEA, SULPHUR IODATUM, SUS SCROFA PARATHYROID GLAND, SYMPHYTUM OFFICINALE, URTICA URENS, VITAMIN DApex Energetics Inc.bd09a34f-1615-09f0-e053-2995a90ac2ef2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
D09 SNS-DRNAMBROSIA ARTEMISIAEFOLIA, ARALIA RACEMOSA, ARNICA MONTANA, CALENDULA OFFICINALIS, CHROMICUM ACIDUM, ECHINACEA PURPUREA, EUCALYPTOL, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC VACCINUM, MERCURIUS IODATUS FLAVUS, MERCURIUS SULPHURATUS RUBER, NATRUM ARSENICICUM, ROSA DAMASCENA, SABADILLA, SANGUINARINUM NITRICUM, SYMPHYTUM OFFICINALEApex Energetics Inc.bc7efab4-7791-9759-e053-2a95a90a31092024-01-08WarningsExact identifier
unii: 660YQ98I10
E08 BIOCLOCK REGULATORBETULA VERRUCOSA, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARUM POSTERIUM, CALCAREA IODATA, COCCULUS INDICUS, COLCHICUM AUTUMNALE, ELEUTHERO, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE, HYPOTHALAMUS, JUNIPERUS COMMUNIS STEM, KALI CARBONICUM, KALI PHOSPHORICUM, LAC CANINUM, NUX VOMICA, PASSIFLORA INCARNATA, ORNITHOGALUM UMBELLATUM, PHOSPHORICUM ACIDUM, RHAMNUS PURSHIANA, RIBES NIGRUM, SARCOLACTICUM ACIDUM, SEPIA, SOLIDAGO VIRGAUREA, SUS SCROFA PINEAL GLAND, TRYPTOPHAN, TYROSINE, YELLOW JASMINEApex Energetics Inc.bf77d8e4-cf1c-447f-e053-2995a90a8c6f2024-01-08WarningsExact identifier
unii: BQN1B9B9HA
F10 WRMLVAGRIMONY, ALOE VERA, AURUM METALLICUM, AZURITE, BASIL, CALENDULA OFFICINALIS, CARICA PAPAYA, CAYENNE, DAFFODIL, DICENTRA FORMOSA, DIPLACUS AURANTIACUS, HIBISCUS CHINENSIS, HORSE CHESTNUT, HYLOTELEPHIUM TELEPHIUM, LAVANDULA STOECHAS, LILIUM TIGRINUM, MALVA NEGLECTA, MELILOTUS ALBA, NELUMBO NUCIFERA, PHOSPHORUS, PRUNELLA VULGARIS, ROSA LUCIAE, ROSEMARY, SCUTELLARIA LATERIFLORA, SEPIA, SILICEA, THUJA OCCIDENTALIS, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, YELLOW JASMINEApex Energetics Inc.bf020c17-578d-74c4-e053-2995a90a9e7d2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
N01 PROTOMERADRENALINUM, ARGENTUM NITRICUM, ARNICA MONTANA, AURUM METALLICUM, AVENA SATIVA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, CHININUM ARSENICOSUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, NATRUM FLUORATUM, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARSAPARILLA, SILICEA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, ZINCUM VALERIANICUMApex Energetics Inc.bfc8e049-2f62-31c4-e053-2a95a90a6e162024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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