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 42 of 63 · 1,247 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepackb5a6b6f2-d073-4bd3-a66c-bf34ccabfe512024-07-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Adrenal HomeopathicCAPSICUM ANNUUM, GLANDULA SUPRARENALIS SUIS, FERRUM METALLICUM, AMMONIUM MURIATICUM, KALI CARBONICUM, NUX VOMICA, PHOSPHORICUM ACIDUMEnergique, Inc.5fe2ae3c-75ca-4907-ac4c-905d34cc5b802024-07-16WarningsExact identifier
unii: BQN1B9B9HA
WINTER BLENDECHINACEA (ANGUSTIFOLIA), UVA-URSI, BAPTISIA TINCTORIA, CONVALLARIA MAJALIS, KALI MURIATICUM, PINUS SYLVESTRIS, THUJA OCCIDENTALIS, BRYONIA, CROTALUS HORRIDUS, LACHESIS MUTUS, SELENIUM METALLICUM, VISCUM ALBUMEnergique, Inc.ff696389-bad5-463a-be99-e92e86250e862024-07-12WarningsExact identifier
unii: 660YQ98I10
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAYEnergique, Inc.c3d2fd24-6b41-4c85-bd5f-c3306e97080e2024-07-03WarningsExact identifier
unii: ETJ7Z6XBU4
Cough plus BronchialANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENSLiddell Laboratories, Inc.801eba42-4217-46e9-8f3e-745da01a27b02024-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Argentum Quartz 6XARGENTUM QUARTZ 6XTrue Botanica, LLC1acadf89-d222-9e16-e063-6294a90a80bc2024-06-26WarningsExact identifier
unii: ETJ7Z6XBU4
Isolyte P in DextroseDEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASICB. Braun Medical Inc.4ea4397c-2fa4-4670-91e6-21ae498c88f72024-06-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
KALI MURKALI MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a3522bc-3d43-ea96-e063-6394a90aa2cc2024-06-06WarningsExact identifier
unii: 660YQ98I10
KALI CARBKALI CARBRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a357f90-5fa9-48df-e063-6394a90a45be2024-06-06WarningsExact identifier
unii: BQN1B9B9HA
SILICEASILICEARxhomeo Private Limited d.b.a. Rxhomeo, Inc1a361030-a925-0998-e063-6394a90a915d2024-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEProficient Rx LPc53d1db5-1c9e-4289-a2a2-961e0dd56f322024-06-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch Prepackd396477a-6b15-4782-9c85-b9663b83c4842024-05-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLCdbed53b7-0109-4561-8342-0178ec8c64b02024-05-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEXLCare Pharmaceuticals, Inc.7fd82f08-8ad0-4ee2-8eb6-5c973f98baee2024-05-21Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Multiple MiasmACONITUM NAPELLUS, ALOE, ARSENICUM ALBUM, AURUM METALLICUM, BRYONIA (ALBA), CACTUS GRANDIFLORUS, CALCAREA SULPHURICA, CINCHONA OFFICINALIS, HURA BRASILIENSIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, PHOSPHORUS, SARCOLACTICUM ACIDUM, SILICEA, STRAMONIUM, SULPHUR, TARENTULA HISPANA, TEUCRIUM MARUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.92c97bf6-8dd9-43a9-b686-75420b0291972024-05-21WarningsExact identifier
unii: ETJ7Z6XBU4
OsteoparEQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OLEUM MORRHUAE, SILICEA, HEKLA LAVAEnergique, Inc.6c346a26-26a2-4be0-b8a3-bbb5709bcf3d2024-05-21WarningsExact identifier
unii: ETJ7Z6XBU4
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepack7a220e87-ff72-417b-bc45-90a37b7f2aa62024-05-21Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
ColoparCOLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALISEnergique, Inc.c47d7203-abcd-4ae5-bf9b-5df07e07d3c12024-05-20WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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