FDA.reportPublic FDA data

NDC 68071-4063-02 - 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
68071-4063-02
Package NDCs from labels
68071-4063-1, 68071-4063-5, 68071-4063-2, 68071-4063-3, 68071-4063-02
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 1 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtropineATROPINE SULFATEGland Pharma Limiteda116af5c-ba4c-408c-9a02-4bc33772aa8d2026-08-03Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEA-S Medication Solutionsf94a0189-40d2-42e0-8d2b-c9dc433faad12026-07-29Warnings, Adverse reactionsExact identifier
application number: ANDA086727
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHenry Schein, Inc.0f5b0961-efe7-42c3-898e-2f7fc7fc90b12026-07-28Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirst768dc21a-b7d9-144c-e053-2991aa0af8892026-06-19Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEREMEDYREPACK INC.3d0e2877-7a74-433f-8a31-e3e54aa9dc9f2026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATERedpharm Drug5342df5c-12bb-565c-e063-6294a90a4ade2026-06-02Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEBryant Ranch Prepackbd08ed90-dd26-4629-83c0-0f75af6ebb952026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA086727
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
PhenohytroPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDEATLANTIC BIOLOGICALS CORP.a5aaf1db-1938-4073-9da4-c47f959d013e2026-05-19Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHospira, Inc.ad8916e7-206e-409e-2582-30d072845dd42026-05-18Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine sulfateATROPINE SULFATEEdenbridge Pharmaceuticals LLC.b39f5876-5d6f-4a8f-bd24-bd4be24ff5682026-05-07Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEPreferred Pharmaceuticals Inc.46d5b27b-a710-4767-b308-4f673ddb354c2026-04-06Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.46ba6000-b842-449a-8dd4-7bb9dc7a74c52026-04-03Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
MotofenDIFENOXIN AND ATROPINE SULFATELegacy Pharma USA Inc.1fa11c67-5492-469c-9475-6bfa0e5e9ff82026-03-23Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
atropine sulfateATROPINE SULFATEAlcon Laboratories, Inc.c8093125-ed1a-4eb6-9c81-52c5c73764812026-03-13Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5