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 15 of 28 · 545 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sciatica-Nerve CareACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA URNewton Laboratories, Inc.9cbd3056-3c1a-916d-e053-2a95a90aa2432025-02-10WarningsExact identifier
unii: 8SKN0B0MIM
Sciatica-Nerve CareACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA URNewton Laboratories, Inc.9cbda496-ef30-18af-e053-2995a90a23212025-02-10WarningsExact identifier
unii: 8SKN0B0MIM
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.9d38fd5a-1657-11e5-e053-2a95a90a47ee2025-02-10WarningsExact identifier
unii: 8SKN0B0MIM
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.9d399697-69dc-217d-e053-2a95a90a65e42025-02-10WarningsExact identifier
unii: 8SKN0B0MIM
Rheumatic-Joint CareURICUM ACIDUM, ACONITUM NAP.,APIS MEL., ARNICA, ARSENICUM ALB, BELLADONNA,BENZOICUM ACIDUM, BRYONIA, CALC. CARB., CHAMOMILLA, CINCHONA, COLCHICUM, EUPATORIUM PERF., GAULTHERIAPROCUMBENS, GUAIACUM, IODIUM, KALI BIC, KALMIA,LEDUM, PULSATILLA, RHUS TOXICODENDRON, RUTA,SABINA, STRYCHNINUM, LAPPA, PHYTOLACCA, SYMPHYTUM,Newton Laboratories, Inc.9cae7d07-19f5-f661-e053-2995a90a944d2025-02-10WarningsExact identifier
unii: 8SKN0B0MIM
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0cd92b-905d-f90f-e053-2995a90a47052025-02-07WarningsExact identifier
unii: 8SKN0B0MIM
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0d8c82-6c4f-a511-e053-2995a90a793f2025-02-07WarningsExact identifier
unii: 8SKN0B0MIM
Lymphatic CareECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..Newton Laboratories, Inc.9c3507de-1def-4019-e053-2a95a90a14752025-02-07WarningsExact identifier
unii: 8SKN0B0MIM
Lymphatic CareECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..Newton Laboratories, Inc.9c36201a-2153-0600-e053-2995a90a6bbf2025-02-07WarningsExact identifier
unii: 8SKN0B0MIM
Code Red Eye Drops Redness ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL4 Trees, LLC0aa08018-cc2d-d947-e063-6394a90a914a2025-02-07WarningsExact identifier
unii: B697894SGQ
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
DiazepamDIAZEPAMAsclemed USA, Inc.32e7bfa1-6060-4041-a0e5-249cacb84ebc2025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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