FDA.reportPublic FDA data

NDC 68071-4063-01 - Diphenoxylate Hydrochloride and Atropine Sulfate

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
68071-4063
Requested NDC
68071-4063-01
Package NDCs from labels
68071-4063-1, 68071-4063-5, 68071-4063-2, 68071-4063-3, 68071-4063-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx onlyNuCare Pharmaceuticals,Inc.2024-07-18HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-4063-12023-05-02Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-22023-05-02Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-32023-05-02Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-52023-05-02Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-12023-01-30Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-22023-01-30Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-32023-01-30Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-52023-01-30Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-12021-02-12Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-22021-02-12Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-32021-02-12Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-52021-02-12Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-12021-01-29Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-22021-01-29Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-32021-01-29Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-52021-01-29Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4063-1Diphenoxylate Hydrochloride and Atropine Sulfate10 in 1 BOTTLETABLET106
68071-4063-2Diphenoxylate Hydrochloride and Atropine Sulfate20 in 1 BOTTLETABLET206
68071-4063-3Diphenoxylate Hydrochloride and Atropine Sulfate30 in 1 BOTTLETABLET306
68071-4063-5Diphenoxylate Hydrochloride and Atropine Sulfate15 in 1 BOTTLETABLET156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4063DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 4 package rows20240720_575c38b4-7ec0-6d25-e053-2a91aa0a80fc.zip

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 4 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atropine SulfateATROPINE SULFATEHikma Pharmaceuticals USA Inc.a66eecf9-2d8b-4e2d-8a05-d718dcbc35422025-10-08Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEAccord Healthcare, Inc.,c82cb295-ffce-47d6-97ad-a8aa723f4e4f2025-10-06Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLC3fa81939-4495-28d5-e063-6394a90a1f2d2025-09-25Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEProPharma Distribution3ef1a1a0-93c1-e6b6-e063-6294a90aa2b62025-09-17Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATE INJECTIONProPharma Distribution3eeed115-0e17-c4b2-e063-6294a90a29b72025-09-16Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEProPharma Distribution3eef6300-9c78-82b2-e063-6294a90a54992025-09-16Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEAmerican Health Packagingd0a1c80d-6aae-4886-8c25-e2d29ca0836b2025-07-30Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: C151H8M554
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEHikma Pharmaceuticals USA Inc.88ed4ccf-9e35-4142-a5eb-d2b5edd369562025-06-26Warnings, Adverse reactionsExact identifier
unii: W24OD7YW48
unii: 03J5ZE7KA5
Atropine sulfateATROPINE SULFATESomerset Therapeutics, LLCe30491ed-938e-4ef4-aa23-a2e94cbab0ed2025-05-29Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: C151H8M554
ShameADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALISDeseret Biologicals, Inc.090e4a23-3e1b-4b0c-a0cc-0172b05f7b642025-05-07WarningsExact identifier
unii: C151H8M554
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEPD-Rx Pharmaceuticals, Inc.700aad61-fa8c-4ded-87b8-da966093075a2025-04-17Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHenry Schein, Inc.d4839e54-b350-4643-8e6e-f0437f5349d62025-04-17Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEBausch & Lomb Incorporatedaeab333c-3cdb-45c0-9e22-949624d69fbc2025-04-14Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
Atropine SulfateATROPINE SULFATEInternational Medication Systems, Limitedb72d0a82-6163-460f-965a-12f6da47370a2025-01-31Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Bestmade Natural Products BM26ARSENIC ALBD7, ATROPIN SULPHD6, BLATTA ORID3, GRINDELIAD3, IPECACD6, NAPHTHALINUMD7, SPONGIA TOSTAD4Bestmade Natural Productsedeead06-a25e-58c4-e053-2a95a90a6a062025-01-23WarningsExact identifier
unii: 03J5ZE7KA5
Bestmade Natural Products BM30ARG NITD3, ATROPIN SULPHD6, BUFO RAND10, CUPRUM ACETICD3, OENANTHE CROCD5, ZINC VALERIAND2Bestmade Natural Productsef0668d6-9c57-8b3e-e053-2995a90a6ba42025-01-23WarningsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATERedpharm Drug Inc.f4c35a82-5927-5bc2-e053-2a95a90aea4d2025-01-23Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

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