Amitriptyline Hydrochloride
- Product NDC
- 10544-110
- 11-digit product format
- 105440110
- Labeler code
- 10544
- Product ID
- 10544-110_8f689b85-94ab-423e-94b6-de77fc212ea1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA085968
- Marketing category
- ANDA
- Marketing start
- 2010-03-03
- Marketing end
- 0000-00-00
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 10544-110-30 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 10544-110-60 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 10544-110-90 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
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 [BLENHEIM PHARMACAL, INC.] | 1 | |
| AMITRIPTYLINE | ACTIVE MOIETY | 1806D8D52K | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-110 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 3 package rows | 20100422_6419e8b2-02cc-45ce-9ae1-94dee861f2b9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-110-30 | 10544011030 | 30 in 1 BOTTLE | Historical |
| 10544-110-60 | 10544011060 | 60 in 1 BOTTLE | Historical |
| 10544-110-90 | 10544011090 | 90 in 1 BOTTLE | Historical |