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 24 of 63 · 1,247 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinnitus FormulaCIMICIFUGA RACEMOSA, GINKGO BILOBA, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, SULPHUR, CEREBELLUM (SUIS), EAR (SUIS) DIGITALIS PURPUREA, KALI CARBONICUMNutritional Specialties, Inc.4885c23c-093c-4ea0-8061-83cdeab9902e2025-10-06WarningsExact identifier
unii: BQN1B9B9HA
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: ETJ7Z6XBU4
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.cc15ef60-6956-4d34-b86d-72cdd0c0c0bb2025-10-02Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMCoupler LLC40074ed8-0799-e3e0-e063-6394a90ad2002025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197466
unii: 63FN7G03XY
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEGranules Pharmaceuticals Inc.b3d4d5b5-2898-ae3d-e053-2a95a90a6d042025-09-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEGranules Pharmaceuticals Incc1f4832d-4d5c-8c49-e053-2a95a90ac9fe2025-09-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepack0e875691-7372-46ac-80a1-946e08b400612025-09-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Cloveden Vegan Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD3fb16579-7cf1-873a-e063-6294a90a9ac12025-09-26WarningsExact identifier
unii: ETJ7Z6XBU4
Potassium ChloridePOTASSIUM CHLORIDEEpic Pharma, LLC00615fad-ad3b-46e8-a89d-48290d937ae22025-09-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEMacleods Pharmaceuticals Limited89d827c8-91af-4bfd-a846-62e55824e9832025-09-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEMajor Pharmaceuticalsa9d68a40-75e3-4c5c-b5d7-1d6160527fa72025-09-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Vax-SodeTHUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI, MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICANutritional Specialties, Inc.cd570e98-c73f-4b38-b5b9-9f16f745ca192025-09-22WarningsExact identifier
unii: ETJ7Z6XBU4
LibidoHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9c334fbd-0c1e-eac0-e053-2995a90a92832025-09-19WarningsExact identifier
unii: ETJ7Z6XBU4
unii: BQN1B9B9HA
LibidoHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9c348fa7-1d68-4975-e053-2995a90a0ca62025-09-19WarningsExact identifier
unii: ETJ7Z6XBU4
unii: BQN1B9B9HA
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: BQN1B9B9HA
Potassium ChloridePOTASSIUM CHLORIDENCS HealthCare of KY, LLC dba Vangard Labs542e16b0-44db-490f-b44e-4c88a6e3d8b82025-09-17Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEStrides Pharma Science Limited0224e5b3-3c49-4e6e-aa78-1abcc69692462025-09-17Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Owell Naturals Draw Salve, Arnica, SiliceaARNICA MONTANA HPUS, SILICEA HPUSOwell Naturals Brand LLC1c9dab31-de1f-911b-e063-6294a90a03912025-09-12WarningsExact identifier
unii: ETJ7Z6XBU4
Owell Naturals Draw SalveARNICA MONTANA HPUS, SILICEA HPUSOwell Naturals Brand LLC1536ff1e-16b8-fbbc-e063-6394a90a628e2025-09-12WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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