FDA.reportPublic FDA data

NDC 70710-1230-00 - Amitriptyline Hydrochloride

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
70710-1230
Requested NDC
70710-1230-00
Package NDCs from labels
70710-1230-1, 70710-1230-0, 70710-1230-00
Manufacturer
Coupler LLC | Zydus Pharmaceuticals USA Inc.
Effective date
2026-04-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amitriptyline Hydrochloride Tablets, USPCoupler LLC | Zydus Pharmaceuticals USA Inc.2026-04-27HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2025-03-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1230-0Amitriptyline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10005
70710-1230-1Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1230AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20250406_73669354-babc-4687-a4fe-ad0fc1f863ba.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1230-1EA - Each70710-123036952988-186c-4628-9481-c087ecd7cd9512018-07-03

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 32 of 140 · 2,791 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RET Heart 7009RET HEARTProfessional Complementary Health Formulase2bf8331-1c50-4216-93a4-1d3cf64047592026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lumbar Drops 5013LUMBAR DROPSProfessional Complementary Health Formulasee6b54ea-fb6a-4723-8a0f-970aa82fea802026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Rehydration Drops 2175REHYDRATION DROPSProfessional Complementary Health Formulas58cc2bd1-c530-43bf-876e-f30d4d95b8da2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Dysfunctional Bleeding Drops 2138DYSFUNCTIONAL BLEEDING DROPSProfessional Complementary Health Formulas3e674c1e-c64b-416d-962f-c03493e800852026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Cervical Drops 5002CERVICAL DROPSProfessional Complementary Health Formulasedd5f196-1423-4d4c-a8c1-89427c4f387e2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Asbestox 6005ASBESTOXProfessional Complementary Health Formulas90bc0d00-01e4-4134-809e-e216fd09852a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
H-Clenz Drops 2026H-CLENZ DROPSProfessional Complementary Health Formulas5dd76d36-e3db-472a-82f8-30643e49eaf72026-01-08WarningsExact identifier
unii: LMI26O6933
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Fourth Chakra (Heart) 7304FOURTH CHAKRA (HEART)Professional Complementary Health Formulasef061447-42ae-43d0-b6f3-bf19a96ffe922026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Spinal Drops 5025SPINAL DROPSProfessional Complementary Health Formulasca6d7250-9c9e-40a6-8d41-88aba33d21dd2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Fifth Chakra (Throat) 7305FIFTH CHAKRA (THROAT)Professional Complementary Health Formulasb731f708-10a8-451f-8550-1e7302102b962026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Alumina Combination 9204ALUMINA COMBINATIONProfessional Complementary Health Formulas312cac13-2009-4b8f-a09b-9be2d2801df52026-01-08WarningsExact identifier
unii: LMI26O6933
Alopecia Formula 2139ALOPECIA FORMULAProfessional Complementary Health Formulasce0eaf67-a435-4167-b9ce-c0ff1f8a9dc22026-01-08WarningsExact identifier
unii: LMI26O6933
Sixth Chakra (Third Eye) 7306SIXTH CHAKRA (THIRD EYE)Professional Complementary Health Formulas174024e7-e231-456c-bc00-48a358d7160a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Injury Drops 2034INJURY DROPSProfessional Complementary Health Formulas024011a0-6471-4016-86d4-19eeb21f0d822026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Colic Drops 2155COLIC DROPSProfessional Complementary Health Formulas17b9e92f-f4ed-48b4-ab02-8b7cba0a20272026-01-08WarningsExact identifier
unii: LMI26O6933
Third Chakra (Solar Plexus) 7303THIRD CHAKRA (SOLAR PLEXUS)Professional Complementary Health Formulaseea89c37-ab87-4cc7-8dfc-e7f42a580dd92026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 1K09F3G675
Hawaiian Blend Extreme Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group4084dd98-357f-4011-b0d4-db6536d2931f2026-01-07WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Blend Extreme Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group9b4acc5e-fdaf-4fcb-83a9-69e430dd43de2026-01-07WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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