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 8 of 63 · 1,247 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepack9088ca44-5585-4551-8e2c-168f306520d42026-03-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
B Force HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEABioActive Nutritional, Inc.811c6f32-fcad-464c-bcf6-ae6a59195b1c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
ANX HPARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUMBioActive Nutritional, Inc.96035891-aea3-4138-bb26-801ad819f6392026-03-30WarningsExact identifier
unii: BQN1B9B9HA
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.c512f211-f4f8-46f6-87ed-dd50287359df2026-03-27WarningsExact identifier
unii: ETJ7Z6XBU4
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepackf98cac25-63f2-478e-b785-20cba1c565652026-03-27WarningsExact identifier
unii: 3A3U0GI71G
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: BQN1B9B9HA
CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma LLC919cbd07-f587-4005-acff-26213dd1d1fb2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197465
rxcui: 197466
rxcui: 197464
unii: 63FN7G03XY
A plus AttentionBARYTA CARBONICA, CALCAREA PHOSPHORICA, SILICEA, GELSEMIUM SEMPERVIRENS, NUX VOMICA, SINAPIS NIGRANaturalCaree77c2661-7ddf-4b09-b2e3-b9db3911011a2026-03-24WarningsExact identifier
unii: ETJ7Z6XBU4
Potassium ChloridePOTASSIUM CHLORIDEAjenat Pharmaceuticals LLCab066a84-5455-419e-a1da-354a3f15a73d2026-03-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Nail Fungus ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Natureb7239e23-326e-4c1d-a080-55f457f1c4542026-03-19WarningsExact identifier
unii: ETJ7Z6XBU4
EarBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, CAPSICUM ANNUUM, CHAMOMILLA, FERRUM PHOSPHORICUM, KALI MURIATICUM, PLANTAGO MAJOR, PULSATILLA (PRATENSIS)BioActive Nutritional, Inc.82774eed-a906-4a19-86d9-05ea1462bd612026-03-18WarningsExact identifier
unii: 660YQ98I10
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLABioActive Nutritional, Inc.12f1ef62-93f3-45b8-885d-1b82f85a83552026-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO17CALC FLUOR, FERR PHOS, KALI MUR, KALI PHOS.BM Private Limited4d22be93-c5f9-6ef3-e063-6294a90a7a8f2026-03-16WarningsExact identifier
unii: 660YQ98I10
BM BIO18CALC FLUOR, CALC SULF, SILICEA.BM Private Limited4d269a3b-18ba-3ad2-e063-6294a90a1fae2026-03-16WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO10CALC PHOS, FERR PHOS, KALI MUR.BM Private Limited4d271d53-5a12-3567-e063-6294a90a37572026-03-16WarningsExact identifier
unii: 660YQ98I10
DrainageECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHURBioActive Nutritional, Inc.7e573986-60c2-40df-9e28-e7f1d9fe1a992026-03-13WarningsExact identifier
unii: 660YQ98I10
LigatoneARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEABioActive Nutritional, Inc.3a3bdd55-daec-43b9-a380-54a747fb7d102026-03-13WarningsExact identifier
unii: ETJ7Z6XBU4
unii: BQN1B9B9HA
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepackff44dcd5-b255-4d80-83ee-3c8f922c99eb2026-03-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: 660YQ98I10
Lower GI and Probiotic RestorationAETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.King Bio Inc.2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff932026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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