FDA.reportPublic FDA data

NDC 70710-1229-01 - 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
70710-1229
Requested NDC
70710-1229-01
Package NDCs from labels
70710-1229-1, 70710-1229-0, 70710-1229-01
Manufacturer
Coupler LLC | Zydus Pharmaceuticals USA Inc.
Effective date
2026-08-21
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.2026-08-21HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2025-03-25HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2021-04-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1229-0Amitriptyline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10005
70710-1229-1Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1229AMITRIPTYLINE 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
70710-1229-1EA - Each70710-12295eafc4a8-1e65-47e3-91da-fe86272fda7012018-07-03

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 68 of 143 · 2,844 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BONE HPSODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE CRUDE, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, EUPATORIUM PERFOLIATUM FLOWERING TOP, IRON, HYDROFLUORIC ACID, HEKLA LAVA, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SILICON DIOXIDE, COMFREY ROOT.Natural Creations, Inc.93d2b385-9ce3-4d16-b428-1638e9a55f922025-11-13WarningsExact identifier
unii: ETJ7Z6XBU4
Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTEDTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.279a5214-79b2-44e9-b003-378d0b9923952025-11-11WarningsExact identifier
unii: 15FIX9V2JP
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.43454445-b9cf-1378-e063-6294a90a1cc62025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210086
rxcui: 856783
unii: 26LUD4JO9K
buttah Tinted Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEButtah Enterprises, LLC.43458152-0775-dd9c-e063-6394a90a61402025-11-10WarningsExact identifier
unii: 15FIX9V2JP
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
unii: 1K09F3G675
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
unii: 1K09F3G675
LUMOe SKIN1 Skin RemedyKALI MURIATICUM, PRUNUS SPINOSA, SILICEA, SARSAPARILLAApplied Bioenergetics, LLCd4d7fd2f-66bf-407d-ad36-2462e880b9f52025-11-10WarningsExact identifier
unii: ETJ7Z6XBU4
Walgreens SPF 50 Tinted Mineral FluidTITANIUM DIOXIDEWalgreens345918e3-95f8-404c-e063-6394a90a3fca2025-11-09WarningsExact identifier
unii: 15FIX9V2JP
Ananassa ResinaANANASSA RESINAUriel Pharmacy Inc.52a18d0a-2c97-4e81-81ff-c836582d0a4c2025-11-07WarningsExact identifier
unii: ETJ7Z6XBU4
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 500 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.d690d5d1-e1fa-404f-a17e-7b97be17b44a2025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 510 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.2fbdeff7-4880-49ef-bb4d-e033d18e04592025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 540 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.6a86e5fd-6736-45e0-aa7d-d268fdaed4f82025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 560 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.42a3625f-5c58-4ec5-895f-b14f744282712025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 415 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8e14fe81-cf7f-4a81-afec-e6c8466179c92025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 425 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.7dd9f4cb-78d8-4edc-a63c-d4a02930a0f82025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8acb660f-94bd-4c4f-b0c1-3682cf8ed5432025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC SPF 30 Fair 150 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.fad2bec7-c5f4-45f4-aff4-a5022033cb6a2025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC SPF 30 Medium 355 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.39856c69-84fb-4b12-a713-8912263e42b12025-11-07WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCeeb3c173-b280-76e4-e053-2995a90a0e792025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCefcd52c2-4208-46a1-e053-2a95a90a857d2025-11-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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