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 30 of 139 · 2,763 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Large Ring Combination 9302LARGE RING COMBINATIONProfessional Complementary Health Formulascced8a69-7bc0-42ad-b80a-58fc603bf7652026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Domestic Animals Nosode Combination 9407DOMESTIC ANIMALS NOSODE COMBINATIONProfessional Complementary Health Formulas222c28aa-e07b-4706-9fb5-585b190f1c5b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
BADABOOM SUNSCREENSUNSCREENAopline Biotechnology (Guangzhou) Co., Ltd.47dbf363-2892-4530-e063-6294a90abe1f2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
ROE WELLNESS SPF 50 MINERALSPF 50 MINERAL POWDERAopline Biotechnology (Guangzhou) Co., Ltd.47dc8155-4abb-4bb7-e063-6294a90af1ad2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
ALOHA MINERAL BLOCK-BRUSH ON MINERALSUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.47dd07aa-71b4-5d54-e063-6394a90a41272026-01-08WarningsExact identifier
unii: 15FIX9V2JP
RamelteonRAMELTEONUpsher-Smith Laboratories, LLC2d22e6ae-2373-4a2f-8dda-d223230c60102026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
unii: 15FIX9V2JP
HM-B (EDIBLE VINEGAR)TITANIUM OXIDEDEMAND SERVICE, CO., LTD.9a7b1e74-b8af-449c-e053-2995a90a349e2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Thyroid/Adrenal 7011RET THYROID/ADRENALProfessional Complementary Health Formulaseb313eb9-4dfc-402e-92b3-14f09f4ba8692026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph Stim Liquescence 3016LYMPH STIM LIQUESCENCEProfessional Complementary Health Formulasd91939ea-e3dc-49b1-949a-6618a4c4ae0d2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Nitrogen Combination 9310NITROGEN COMBINATIONProfessional Complementary Health Formulas72a7c0f3-0a57-4aa8-8fe8-a3267b9acd532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pneumonia/Meningitis Nosode Combination 9414PNEUMONIA/MENINGITIS NOSODE COMBINATIONProfessional Complementary Health Formulas823de3e3-4d20-446c-988d-d7a70a747f9a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Large Intestine Formula 2103LARGE INTESTINE FORMULAProfessional Complementary Health Formulas532eb4c6-0f3f-4853-89e2-43168e118d652026-01-08WarningsExact identifier
unii: XM0M87F357
Childhood Immunization Detox 6032CHILDHOOD IMMUNIZATION DETOXProfessional Complementary Health Formulas4d455d07-3197-44d6-99d6-488fcdb50f952026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy Nosode 4017ALLERGY NOSODEProfessional Complementary Health Formulasda9145a5-42e9-4dba-9d11-195848e628a42026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bone Stim Liquescence 3005BONE STIM LIQUESCENCEProfessional Complementary Health Formulas6e62dde0-adf2-4cdd-8340-abc6b10db3572026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Connective Tissue Liquescence 3024CONNECTIVE TISSUE LIQUESCENCEProfessional Complementary Health Formulasb7dab801-0256-40d7-8f66-7a0e7e76c3532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Childhood Vaccination Nosode Combination 9409CHILDHOOD VACCINATION NOSODE COMBINATIONProfessional Complementary Health Formulasa7a262f1-fe38-4e6b-aefa-f9e8a914f38e2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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