Amitriptyline Hydrochloride
- Product NDC
- 50436-3073
- 11-digit product format
- 504363073
- Labeler code
- 50436
- Product ID
- 50436-3073_32fefe57-a9f6-44ae-8ea5-b1fdc2b60992
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA040218
- Marketing category
- ANDA
- Marketing start
- 1997-09-11
- Marketing end
- 0000-00-00
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50436-3073-1 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 50436-3073-2 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | ACTIVE INGREDIENT | 26LUD4JO9K | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| AMITRIPTYLINE | ACTIVE MOIETY | 1806D8D52K | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-3073 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 4 | Legacy NDC, 2 package rows | 20170702_063d2b43-87e6-443d-82e4-d93aaee269a8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 50436-3073-1 | 50436307301 | 30 in 1 BOTTLE | Historical |
| 50436-3073-2 | 50436307302 | 60 in 1 BOTTLE | Historical |