NDC 70710-1230-01 - 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
- 70710-1230
- Requested NDC
- 70710-1230-01
- Package NDCs from labels
- 70710-1230-1, 70710-1230-0, 70710-1230-01
- 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 | Type |
|---|---|---|---|
| Amitriptyline Hydrochloride Tablets, USP | Coupler LLC | Zydus Pharmaceuticals USA Inc. | 2026-04-27 | HUMAN PRESCRIPTION DRUG LABEL |
| AMITRIPTYLINE - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2025-03-25 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70710-1230-0 | Amitriptyline Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 5 | |
| 70710-1230-1 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70710-1230 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250406_73669354-babc-4687-a4fe-ad0fc1f863ba.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70710-1230-1 | EA - Each | 70710-1230 | 36952988-186c-4628-9481-c087ecd7cd95 | 1 | 2018-07-03 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | Shiseido Americas Corporation | b93f10dc-193d-4cda-94b6-3f0e54d89f21 | 2026-02-23 | Warnings | 15FIX9V2JP |
| SHISEIDO ULTIMATE SUN PROTECTOR MINERAL | TITANIUM DIOXIDE AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 5e31eee8-6532-47ea-99fc-22418791804b | 2026-02-23 | Warnings | 15FIX9V2JP |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 8b10ac1a-cf66-4efa-9abc-498b2f8a1613 | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | 856853 26LUD4JO9K |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | cf03c1a1-cbd5-47dc-a5e8-70ec32b71cb1 | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | 856762 26LUD4JO9K |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | b2f822aa-23c0-4833-afc8-f5a611b9ad5a | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | 856834 26LUD4JO9K |
| Allergy Maximum Strength | URTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDE | Forces of Nature | 122ca23e-43f1-4e5c-afc2-1418b1717679 | 2026-02-20 | Warnings | ETJ7Z6XBU4 |
| Perfect Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | SKIN PERFECT MEDICAL | 4b47e7cb-17d6-6a7c-e063-6294a90abbea | 2026-02-20 | Warnings | 15FIX9V2JP |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 5dd07852-43a5-415c-863e-1202f82b5654 | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | 856783 26LUD4JO9K |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ba6a83c4-2993-40ca-bb8f-2d6c5c3e3e26 | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | 856834 26LUD4JO9K |
| Calamine | FERRIC OXIDE RED | Perrigo Direct, Inc | 256bd1d4-fd50-408f-9aee-84f218bb4971 | 2026-02-19 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | CALAMINE, PRAMOXIND HCL | Perrigo Direct, Inc | 54a20ec9-ab86-4410-af94-e04393e9d4b3 | 2026-02-19 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | CALAMINE, PRAMOXINE HCL | Meijer, Inc. | 6b369ef2-fd54-4931-a9eb-0fb42834c2ef | 2026-02-19 | Warnings, Adverse reactions | 1K09F3G675 |
| Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42 | TITANIUM DIOXIDE, ZINC OXIDE | ALLAY SKIN SOLUTIONS LLC | 425bf1d7-f2cf-4237-9047-dd53054acd1c | 2026-02-18 | Warnings | 15FIX9V2JP |
| Calamine | FERRIC OXIDE RED | Target Corporation | d4ee05c8-ae62-45df-8783-1ed57fa030ec | 2026-02-18 | Warnings, Adverse reactions | 1K09F3G675 |
| Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN | TITANIUM DIOXIDE | S.A. COMPTOIR NOUVEAU DE LA PARFUMERIE | dacff3dc-49d7-6416-e053-2a95a90a85c6 | 2026-02-18 | Warnings | 15FIX9V2JP |
| Mitochondria Pro | ARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM, | Energique, Inc. | 2f365207-b730-428d-9465-8853e86e79ff | 2026-02-18 | Warnings | ETJ7Z6XBU4 |
| BIO COM 25 ACIDITY | NAT PHOS, NAT SULPH, SILICEA | BM Private Limited | 3b3c3455-b321-071d-e063-6394a90a0160 | 2026-02-17 | Warnings | ETJ7Z6XBU4 |
| CINA | AMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEA | BM PRIVATE LIMITED | 3b3c0874-90b5-deda-e063-6394a90a7802 | 2026-02-15 | Warnings | ETJ7Z6XBU4 |
| Acne/Pimple Control | CALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDE | Forces of Nature | e871e46e-463e-49ec-a2af-5aa98548ee12 | 2026-02-13 | Warnings | ETJ7Z6XBU4 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 5fe84552-9650-42e4-9870-add97b46dfe1 | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | 856845 26LUD4JO9K |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.