FDA.reportPublic FDA data

NDC 43386-280-01 - Diazepam

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
43386-280
Requested NDC
43386-280-01
Package NDCs from labels
43386-280-03, 43386-280-01, 43386-280-02
Manufacturer
Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc.
Effective date
2025-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diazepam - Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc.Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc.2025-12-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-280-01Diazepam2 in 1 PACKAGEGEL28
43386-280-02Diazepam1 in 1 CARTONGEL18
43386-280-03Diazepam2 g in 1 SYRINGEGEL28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-280DIAZEPAM GEL [LUPIN PHARMACEUTICALS,INC.]7Current NDC, 3 package rows20231216_d99b68aa-b3dc-49c8-8894-3da255cd26b0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-280-03EA - Each43386-2807397c482-2c8a-4d7d-94bf-06adcd4a78dc12024-01-04

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 20 of 28 · 545 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMBryant Ranch Prepacke8e4d5f5-3b4c-4c0f-a818-9da86389473c2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 6DC9Q167V3
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
DetoxifierURICUM ACIDUM, BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DIOSCOREA, DOLICHOS, IRIS VERSICOLOR, JUNIPERUS COM., NUX VOM.,PTELEA,TARAXACUM, CARDUUS MAR., CYNARA SCOLYMUS, SOLIDAGO,TARAXACUMNewton Laboratories, Inc.9af2f55c-f5b5-6fe9-e053-2a95a90ace0c2024-03-07WarningsExact identifier
unii: 8SKN0B0MIM
ImmunogesicARNICA MONTANA, APIS MELLIFICA, BENZOICUM ACIDUM, CARTILAGO SUIS, LEDUM PALUSTRE, PANTOTHENIC ACID, RUTA GRAVEOLENS, RHODODENDRON CHRYSANTHUM, CAUSTICUM, FORMICA RUFA, SEPIA, ALPHA-LIPOICUM ACIDUM, AURUM METALLICUM, CALCAREA PHOSPHORICA, COLCHICUM AUTUMNALE, PHYTOLACCA DECANDRA, RADIUM BROMATUM, RHUS VENENATA, THUJA OCCIDENTALIS, LAC CANINUMDeseret Biologicals, Inc.a7363a92-bcef-450e-9168-39f51a57cf3e2024-03-07WarningsExact identifier
unii: 8SKN0B0MIM
InflammationARNICA MONTANA, BENZOICUM ACIDUM, ECHINACEA (ANGUSTIFOLIA), APIS MELLIFICA, BAPTISIA TINCTORIA, DULCAMARA, EUCALYPTUS GLOBULUS, SOLANUM NIGRUM, EUPATORIUM PERFOLIATUM, BRYONIA (ALBA), COLCHICUM AUTUMNALE, MERCURIALIS PERENNIS, RHUS TOXDeseret Biologicals, Inc.98578714-8408-4bc0-82ff-faa88cda37572024-03-05WarningsExact identifier
unii: 8SKN0B0MIM
Benzoicum acidumBENZOIC ACIDBoiron8477f330-a9b5-4e03-e053-2991aa0af6ab2024-02-27Exact identifier
unii: 8SKN0B0MIM
Benzoicum acidumBENZOIC ACIDBoiron6c41ab9f-d45b-fc18-e053-2a91aa0ae2352024-02-27Exact identifier
unii: 8SKN0B0MIM
BENZOICUM ACIDUMBENZOIC ACIDBoiron124e1676-96fd-1a52-e063-6294a90a901f2024-02-26Exact identifier
unii: 8SKN0B0MIM
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Kidney DrainageSOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUMDeseret Biologicals, Inc.a030afc6-9248-4e6a-a814-bd700c053e5c2024-02-20WarningsExact identifier
unii: 8SKN0B0MIM
DiazepamDIAZEPAMA-S Medication Solutionsaf9a7906-4dca-4c1f-b16b-9b666a86b3632024-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
unii: FZ989GH94E
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
unii: FZ989GH94E
DiazepamDIAZEPAMTeva Pharmaceuticals USA, Inc.48aa32cb-047a-414a-822e-82a5f26d88172024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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