NDC 68788-8346-03 - 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
- 68788-8346
- Requested NDC
- 68788-8346-03
- Package NDCs from labels
- 68788-8346-8, 68788-8346-3, 68788-8346-6, 68788-8346-9, 68788-8346-1, 68788-8346-03
- Manufacturer
- Preferred Pharmaceuticals Inc.
- Effective date
- 2026-02-20
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Amitriptyline Hydrochloride Tablets, USP Rx Only | Preferred Pharmaceuticals Inc. | 2026-02-20 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-8346-1 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 4 | |
| 68788-8346-3 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 4 | |
| 68788-8346-6 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 4 | |
| 68788-8346-8 | Amitriptyline Hydrochloride | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | 4 | |
| 68788-8346-9 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8346 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 5 package rows | 20250119_ba6a83c4-2993-40ca-bb8f-2d6c5c3e3e26.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8346-1 | EA - Each | 68788-8346 | 22a240bb-e429-4ffe-ba5a-76eab40c6a74 | 1 | 2023-03-13 |
| 68788-8346-3 | EA - Each | 68788-8346 | 4f20ee6b-fdf7-4c54-b378-24a9cd78060c | 1 | 2023-03-13 |
| 68788-8346-6 | EA - Each | 68788-8346 | 70aaf0bf-adbe-4281-9219-e7d117df230a | 1 | 2023-03-13 |
| 68788-8346-8 | EA - Each | 68788-8346 | 08dd284d-9b66-4a8a-b4f0-3b4b358d9f55 | 1 | 2023-03-13 |
| 68788-8346-9 | EA - Each | 68788-8346 | 3fe65d31-6cfc-4509-8a1c-2ee16532d32a | 1 | 2023-03-13 |
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 |
|---|---|---|---|---|---|---|
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | 61b29703-cfc2-45c7-ae24-7bf3b77e8587 | 2026-09-09 | Boxed warning, Warnings, Adverse reactions | 856762 26LUD4JO9K |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | W Aesthetics | 5b0f2c8f-d6fa-5e25-e063-6394a90a084d | 2026-09-09 | Warnings | 15FIX9V2JP |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | e0aa02a9-3e2d-44c5-a6b9-843c80102249 | 2026-09-08 | Boxed warning, Warnings, Adverse reactions | 856853 26LUD4JO9K |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 4e520c63-1cf6-40f6-a51c-3f9b0e181342 | 2026-09-08 | Boxed warning, Warnings, Adverse reactions | 856834 856853 856783 856845 856773 856762 26LUD4JO9K |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | c072c1b3-ed8a-4f1e-ba6c-580a2b2c8f58 | 2026-09-04 | Boxed warning, Warnings, Adverse reactions | 856834 26LUD4JO9K |
| Dr.Harry EYES PROTECTION | POLYETHYLENE GLYCOL 400 1% EYES PROTECTION | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5a9fe033-89d3-da62-e063-6294a90a4503 | 2026-09-03 | Warnings | B697894SGQ |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | bb02d7b8-8f1a-4cc4-b763-223e6894f02c | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | 856762 26LUD4JO9K |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | 4132f91e-6f24-476a-9028-bab86ad0598e | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | 856834 26LUD4JO9K |
| MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50 | SUNSCREEN SPF50 | Guangzhou Meixi Biotechnology Co., Ltd. | 5a0b4bd2-f6ad-35dc-e063-6294a90a8a66 | 2026-08-27 | Warnings | 15FIX9V2JP |
| MELAO Hydrating Lightweight Sunscreen | AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE | Guangdong Aimu Biological Technology Co., Ltd | 59eeaea1-d726-99f3-e063-6394a90aeea3 | 2026-08-26 | Warnings | 15FIX9V2JP |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | 5dc3c2d7-60a2-4754-be33-1f9401c925a4 | 2026-08-26 | Boxed warning, Warnings, Adverse reactions | 856845 26LUD4JO9K |
| Q Skin Science | SUNSCREEN | International Cosmeceuticals, Inc | 59e4c3d0-ee4c-2350-e063-6394a90ac9d2 | 2026-08-25 | Warnings | 15FIX9V2JP |
| MELAO zinc stick(GREEN) | TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE | Guangzhou Haishi Biological Technology Co., Ltd. | 59c70c82-f7ff-9a04-e063-6294a90a7b3d | 2026-08-24 | Warnings | 15FIX9V2JP |
| SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01 | ZINC OXIDE, TITANIUM DIOXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 59d74e3f-e3fa-a7a9-e063-6294a90a76e5 | 2026-08-24 | Warnings | 15FIX9V2JP |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Coupler LLC | 598f6ffb-45c3-3cfc-e063-6294a90a56d1 | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | ANDA214548 856834 26LUD4JO9K |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Coupler LLC | 598f900c-552b-5653-e063-6294a90aff53 | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | 856762 26LUD4JO9K |
| Sweat Resistant Sunscreen Body Original | TITANIUM DIOXIDE, ZINC OXIDE | Clutch, Inc. | 4bbde755-e312-123e-e063-6294a90a467f | 2026-08-20 | Warnings | 15FIX9V2JP |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | e0d5b1f6-c1f2-4d5b-a1c3-aebe77843df2 | 2026-08-18 | Boxed warning, Warnings, Adverse reactions | 856834 26LUD4JO9K |
| HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN | ZINC OXIDE,TITANIUM DIOXIDE | Guangzhou Tata Biotechnology Co., Ltd. | 4339df13-77d3-31a1-e063-6394a90a5208 | 2026-08-17 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | HAMBLIN DERMATOLOGY | 5942e64c-416e-7525-e063-6394a90a2839 | 2026-08-17 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.