FDA.reportPublic FDA data

NDC 70710-1344-05 - 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
70710-1344-05
Package NDCs from labels
70710-1344-3, 70710-1344-1, 70710-1344-5, 70710-1344-05
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 50 of 136 · 2,716 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf708c-244e-63a8-e063-6394a90a3b962025-12-15Exact identifier
unii: 15FIX9V2JP
Daily Defense Facial Sunscreen Plus PrimerTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e81e8e-0ba7-93e6-e063-6294a90a4e622025-12-15Exact identifier
unii: 15FIX9V2JP
Daily Defense Facial Sunscreen Plus PrimerTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e84147-5dcd-517a-e063-6394a90a54ee2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen Plus Primer MatteTITANIUM DIOXIDE, ZINC OXIDESimply Bare Waxing & Skin Care LLC36d8e8ba-a3dd-257d-e063-6294a90a30d62025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e9e8d7-3fcf-1e94-e063-6394a90a8dc62025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN STUDIO36d45b48-e08d-ef40-e063-6394a90a635c2025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN STUDIO36d439fb-b9cf-2774-e063-6294a90ae8852025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen Plus Primer MatteTITANIUM DIOXIDE, ZINC OXIDESimply Bare Waxing & Skin Care LLC36d9d83b-7da7-a006-e063-6394a90a9d842025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN & ACNE36d3ebc0-1de6-1998-e063-6294a90a02e62025-12-15Exact identifier
unii: 15FIX9V2JP
Sun Safe Lip BalmTITANIUM DIOXIDE, ZINC OXIDEREVIVE IN SOLANO36c4f0c9-5789-ca58-e063-6394a90a23232025-12-15Exact identifier
unii: 15FIX9V2JP
Titanium Dioxide, Zinc OxideON THE GO SUNSCREEN STICKREVIVE IN SOLANO36c57e6f-c747-9926-e063-6294a90a57212025-12-15Exact identifier
unii: 15FIX9V2JP
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC3739bdb8-2152-b2ba-e063-6294a90acd942025-12-15Exact identifier
unii: 15FIX9V2JP
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC37396a51-225d-7669-e063-6294a90af6d32025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Lip Shade SunscreenTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC373a7c01-ba9f-4b00-e063-6294a90ae1a22025-12-15Exact identifier
unii: 15FIX9V2JP
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC373b7ab9-c692-fc1b-e063-6294a90aa8032025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBASS & KLASS, INC36af24e2-015a-a9a7-e063-6294a90a2fce2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEBASS & KLASS, INC36add3a3-f1ff-3986-e063-6394a90ab7fe2025-12-15Exact identifier
unii: 15FIX9V2JP
Mucus and Sinus Mucus and Sinus Symptom ReliefBRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUMTRP Company2a42c4a3-9486-9b29-e063-6294a90a7c702025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Natural Relief Cold and Flu Plus ZincALLIUM CEPA, ARSENICUM ALBUM, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, NATRUM MURIATICUM, NUX VOMICA, SILICEA, SULPHUR, ZINCUM GLUCONICUMTRP Company2a352cf2-48fb-4862-e063-6294a90a2eeb2025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Ring ReliefARNICA MONTANA - CALCIUM SULFIDE - HYPERICUM PERFORATUM - LYCOPODIUM CLAVATUM SPORE - MERCURIUS SOLUBILIS - SALICYLIC ACID - SILICON DIOXIDE - ALLYLTHIOUREA -TRP Companyaa2cd967-3c27-4afe-8751-7ea50ab629132025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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