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 130 of 140 · 2,792 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AluminaALUMINAHahnemann Laboratories, INC.ffdbdb70-8666-f0c6-e053-6394a90a65962023-07-06Exact identifier
unii: LMI26O6933
Kidney DrainageSOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUMDeseret Biologicals, Inc.4f82e261-6101-48ab-b161-ded5aa41cd852023-06-27WarningsExact identifier
unii: ETJ7Z6XBU4
AluminaALUMINUM OXIDEBoirona9603cb0-7c3b-11e6-8197-424c583030312023-06-26Exact identifier
unii: LMI26O6933
CalciforceARNICA MONTANA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), BORON CITRATE, SYMPHYTUM OFFICINALE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, LYCOPODIUM CLAVATUM, SILICEA, CALCAREA CARBONICABioActive Nutritional, Inc.1609ce3e-82c2-4597-86e6-847c944ddbe62023-06-07WarningsExact identifier
unii: ETJ7Z6XBU4
Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium ShadeSPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADEAutumn Harpfd6807e1-c8c0-b361-e053-6294a90aea0c2023-06-05WarningsExact identifier
unii: 15FIX9V2JP
Silicea 6XSILICEA 6XTrue Botanica, LLCfd296871-c491-7d30-e053-6294a90ab64d2023-06-02WarningsExact identifier
unii: ETJ7Z6XBU4
Thinksport Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC77b63c0b-353b-4f5f-95c7-6f7eeab814712023-05-30WarningsExact identifier
unii: 15FIX9V2JP
Think Kids Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC25c59820-a08d-4abe-87ae-a787ac8b2ac22023-05-30WarningsExact identifier
unii: 15FIX9V2JP
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: ETJ7Z6XBU4
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: ETJ7Z6XBU4
AluminaALUMINUM OXIDEBoiron8426bd35-372c-4417-e053-2a91aa0a79032023-04-11Exact identifier
unii: LMI26O6933
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions1a622039-0a79-407c-8f15-2ea0c58441362023-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856762
unii: 26LUD4JO9K
Ferrum OxydatumFERRUM OXYDATUMHahnemann Laboratories, INC.f8b52d3f-3fe2-a850-e053-6394a90a5d9f2023-04-06Exact identifier
unii: 1K09F3G675
AluminaALUMINUM OXIDEBoiron84274737-2fed-d542-e053-2a91aa0a1ead2023-03-28Exact identifier
unii: LMI26O6933
AluminaALUMINUM OXIDEBoiron84270ebe-2cd9-7fb5-e053-2a91aa0ab7d52023-03-27Exact identifier
unii: LMI26O6933
SiliceaSILICON DIOXIDEBoiron86d34721-7dfc-bf91-e053-2991aa0a70ae2023-03-27Exact identifier
unii: ETJ7Z6XBU4
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC8746c047-51b9-4040-aeec-cd1f5b6eb3d42023-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
unii: 26LUD4JO9K
NS SupportBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM,Dr. Donna Restivo DC807fd9cf-13d1-4173-a6da-180f89b67cf22023-03-15WarningsExact identifier
unii: ETJ7Z6XBU4
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.d29af0e7-0d04-47e3-9a50-d99c7e14b44d2023-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d395ec-3c3b-5e5f-e053-2a91aa0a3f9c2023-02-20Exact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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