AMITRIPTYLINE HYDROCHLORIDE
- Product NDC
- 69158-002
- 11-digit product format
- 691580002
- Labeler code
- 69158
- Product ID
- 69158-002_3171e373-6375-4467-b3f0-872e9221a773
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMITRIPTYLINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- GLENVIEW PHARMA INC.
- Application
- ANDA085968
- Marketing category
- ANDA
- Marketing start
- 1977-11-29
- 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
- 2018-12-31
- 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 |
|---|
| 69158-002-00 | AMITRIPTYLINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 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 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| AMITRIPTYLINE | ACTIVE MOIETY | 1806D8D52K | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69158-002 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.] | 4 | Legacy NDC, 1 package rows | 20140910_94e984da-3b08-406f-8c10-e78844fca1ff.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 69158-002-00 | 69158000200 | 100 in 1 BOTTLE | Historical |