FDA.reportPublic FDA data

NDC 70710-1344-01 - Ramelteon

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
70710-1344
Requested NDC
70710-1344-01
Package NDCs from labels
70710-1344-3, 70710-1344-1, 70710-1344-5, 70710-1344-01
Manufacturer
Major Pharmaceuticals
Effective date
2026-03-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ramelteon - Major PharmaceuticalsMajor Pharmaceuticals2026-03-16HUMAN PRESCRIPTION DRUG LABEL
RAMELTEON - DIRECT RXDIRECT RX2025-01-17HUMAN PRESCRIPTION DRUG LABEL
Ramelteon - American Health PackagingAmerican Health Packaging2024-07-19HUMAN PRESCRIPTION DRUG LABEL
Ramelteon - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2023-11-27HUMAN PRESCRIPTION DRUG LABEL
Ramelteon - Bryant Ranch PrepackBryant Ranch Prepack2023-11-09HUMAN PRESCRIPTION DRUG LABEL
Ramelteon - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2023-11-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1344-1Ramelteon100 in 1 BOTTLETABLET1004
70710-1344-3Ramelteon30 in 1 BOTTLETABLET304
70710-1344-5Ramelteon500 in 1 BOTTLETABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1344RAMELTEON TABLET [ZYDUS PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 3 package rows20231110_5db0e3ff-fefb-4c54-b9f9-b555e482e147.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1344-1EA - Each70710-13447dd2034b-7ac4-4eb4-8f38-0b026df9c24612019-08-06
70710-1344-3EA - Each70710-1344376c1037-907a-4be6-857c-31b3450d632312019-08-06

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 49 of 139 · 2,763 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdf417-45ba-f81a-e063-6394a90a74712025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd148c-43c7-aa93-e063-6394a90abc8b2025-12-15Exact identifier
unii: 15FIX9V2JP
Sheer Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd62d8-ebe3-b3fd-e063-6394a90a827c2025-12-15Exact identifier
unii: 15FIX9V2JP
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386bb911-9dbb-30fb-e063-6394a90a5e4d2025-12-15Exact identifier
unii: 15FIX9V2JP
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c0261-68f9-6f27-e063-6294a90a82092025-12-15Exact identifier
unii: 15FIX9V2JP
PURE Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c320b-22c3-7d35-e063-6394a90a4e0b2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdc7f4-4e47-ce35-e063-6294a90acf2d2025-12-15Exact identifier
unii: 15FIX9V2JP
Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724cb53-0198-c604-e063-6294a90aa64b2025-12-15Exact identifier
unii: 15FIX9V2JP
Untinted Sheer DefenseTITANIUM DIOXIDE, ZINC OXIDEKristina Lerner35be50b7-a9af-29ee-e063-6394a90a45ba2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724ea3c-b018-c125-e063-6394a90a01f12025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC37252429-d692-c05a-e063-6294a90a6af62025-12-15Exact identifier
unii: 15FIX9V2JP
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation423c7e62-ad50-0dc3-e063-6294a90ad05a2025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC3699c107-d063-cc6f-e063-6394a90a6ad42025-12-15Exact identifier
unii: 15FIX9V2JP
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation44776529-3aa6-4fa3-b2ce-f624c4cf41bd2025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC36999510-88f0-64fc-e063-6294a90a3d092025-12-15Exact identifier
unii: 15FIX9V2JP
Sunshade Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37dec631-fdaf-fbdf-e063-6394a90a6c2b2025-12-15Exact identifier
unii: 15FIX9V2JP
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37527317-0f10-d7e6-e063-6394a90a35a62025-12-15Exact identifier
unii: 15FIX9V2JP
Sunshade Mineral Stick SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee31be-bfda-f052-e063-6294a90ac0bb2025-12-15Exact identifier
unii: 15FIX9V2JP
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC3751544d-e093-3d19-e063-6394a90aefc32025-12-15Exact identifier
unii: 15FIX9V2JP
Lip CrackTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37edc05c-82c3-90fe-e063-6294a90aa6012025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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