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 95 of 139 · 2,763 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oars and Alps SPF 50 100% Mineral Antioxidant SunscreenTITANIUM DIOXIDE, ZINC OXIDEOars and Alps LLCf3971b85-a13e-4195-e053-2995a90a73cb2024-12-20WarningsExact identifier
unii: 15FIX9V2JP
Carpe SPF 30 Face PrimerTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc. DBA Carpefeac5ee2-faa5-fd17-e053-6394a90a7f992024-12-20WarningsExact identifier
unii: 15FIX9V2JP
Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESmall World Brandsb1df4c81-333b-450d-963e-6670ab9bbda92024-12-20WarningsExact identifier
unii: 15FIX9V2JP
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 8B porcelain beigeTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.062fa0d9-f384-48af-8269-42de3a788db12024-12-20WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 PORCELAINOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299ac9a5-f609-d804-e063-6394a90abd052024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 IVORYOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299ad424-16a8-66b1-e063-6394a90a07532024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NUDEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299afef9-758f-74e1-e063-6294a90a80722024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NATURAL BEIGEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b3276-7973-d33f-e063-6294a90a6ce12024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CLASSIC TANOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299afe24-d496-5745-e063-6394a90aa1b32024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b1f9a-34fd-cb50-e063-6394a90af9252024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SANDOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b3236-3f3d-c9e8-e063-6394a90a74432024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 TAWNYOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b416d-ce02-3462-e063-6294a90a38f02024-12-19WarningsExact identifier
unii: 15FIX9V2JP
PuttisuTITANIUM DIOXIDE, ZINC OXIDEJellycup, Inc.a032331a-6724-d2cd-e053-2995a90ac15a2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
toty Ilumina CC Cream 1NTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe4efe14e-7d46-78c0-e053-2995a90a23642024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CARAMELOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29a82ba9-c0f8-0edf-e063-6294a90a50b42024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SABLEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29a8812b-70ff-e8aa-e063-6294a90a09f82024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Neutral DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONEKW ABSC, INC.3a548deb-3670-4c5b-a139-796701801fed2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Olive Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.be4434c0-cbdd-46cb-8015-4c7859e80d4a2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Golden MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.de50e956-a014-4147-922b-63c95fa6f86b2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Neutral LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.44cbb226-83ed-401b-baf8-ca8e4740dbef2024-12-19WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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