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 33 of 63 · 1,247 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.99fdc906-3a55-e4c4-e053-2a95a90a76ba2025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
Gas-IndigestionCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, DAPHNE INDICA, IPECACUANHA, IRIS VERSICOLOR, KALI CARBONICUM, KREOSOTUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, MERCURIUS VIVUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, SPIGELIA ANTHELMIA, SULPHUR, PYROGENIUMNewton Laboratories, Inc.9a125a53-39c2-d849-e053-2a95a90a98452025-02-10WarningsExact identifier
unii: BQN1B9B9HA
Bestmade Natural Products BM117AGRAPHIS NUTANS, CALC FLUOR, CHENOPODIUM, CHERIANTHUS CHEIRI, CHINA SULPH, KALI MUR, ROSA DAMASCUS, VERBASCUMBestmade Natural Products2d905563-249b-dacf-e063-6394a90a48b32025-02-07WarningsExact identifier
unii: 660YQ98I10
Leg Cramps-SwellingECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPSNewton Laboratories, Inc.9c315126-e61e-f649-e053-2a95a90a7f082025-02-07WarningsExact identifier
unii: ETJ7Z6XBU4
unii: BQN1B9B9HA
MenopauseELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANANewton Laboratories, Inc.9c4872fd-bfe5-2472-e053-2995a90a361f2025-02-07WarningsExact identifier
unii: BQN1B9B9HA
MenopauseELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANANewton Laboratories, Inc.9c4718ef-86ac-7bb7-e053-2a95a90a56272025-02-07WarningsExact identifier
unii: BQN1B9B9HA
Appetite - Craving ControlANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.Newton Laboratories, Inc.7964f0f7-7774-fac6-e053-2a91aa0a3e4a2025-02-06WarningsExact identifier
unii: BQN1B9B9HA
Appetite - Craving ControlANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.Newton Laboratories, Inc.79655acc-f059-e509-e053-2a91aa0ac4882025-02-06WarningsExact identifier
unii: BQN1B9B9HA
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.9bb84bae-9019-ed76-e053-2a95a90a5c3e2025-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.9ba993f4-97af-4119-e053-2995a90a126d2025-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
Ear Wax Build-UpELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATANewton Laboratories, Inc.9302b838-6003-ba6a-e053-2995a90aedd32025-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 660YQ98I10
PRIDICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.d22eca2f-d7e6-3412-e053-2995a90a63842025-02-05WarningsExact identifier
unii: ETJ7Z6XBU4
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMCoupler LLC2d592a27-f4cf-008a-e063-6394a90a26292025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213730
rxcui: 197464
unii: 63FN7G03XY
Jacksons Cell Salts 12 IN 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAZettl Health Inc.25ba49d0-0369-3666-e063-6294a90a71c42025-02-04Exact identifier
unii: ETJ7Z6XBU4
unii: 660YQ98I10
Jacksons Cell Salts SILICA 6X 12SILICEAZettl Health Inc.2d5d1bf7-3754-1f60-e063-6294a90aee062025-02-04Exact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products BM79CARDUUS MAR, HYDRASTIS, KALI MUR, PHYTOLACCIN, POLYGONUM, RUTABestmade Natural Products2cf029ac-5560-84fb-e063-6294a90a06202025-01-30WarningsExact identifier
unii: 660YQ98I10
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.8ca76872-a187-4fd8-8daf-9ee351bdf3462025-01-28WarningsExact identifier
unii: 660YQ98I10
Kali Carbonicum Kit RefillPOTASSIUM CARBONATEWashington Homeopathic Productsdfdb7ca2-8b15-683b-e053-2995a90a3f612025-01-28WarningsExact identifier
unii: BQN1B9B9HA
Kali Muriaticum Kit RefillPOTASSIUM CHLORIDEWashington Homeopathic Products099223af-a3f6-c370-e063-6394a90aa17f2025-01-28WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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