AMITRIPTYLINE HYDROCHLORIDE
- Product NDC
- 16729-174
- 11-digit product format
- 167290174
- Labeler code
- 16729
- Product ID
- 16729-174_ecb5bd74-ba7f-6546-e053-2a95a90a0a30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMITRIPTYLINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA202446
- Marketing category
- ANDA
- Marketing start
- 2014-12-26
- Marketing end
- 0000-00-00
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-174-01 | AMITRIPTYLINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 16729-174-10 | AMITRIPTYLINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 16729-174-17 | AMITRIPTYLINE HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 8 |
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 [ACCORD HEALTHCARE INC.] | 3 | |
| AMITRIPTYLINE | ACTIVE MOIETY | 1806D8D52K | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 3 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 3 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-174 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 8 | Legacy NDC, 3 package rows | 20221106_1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16729-174-01 | 16729017401 | 100 TABLET, FILM COATED in 1 BOTTLE (16729-174-01) | 2014-12-26 | 0000-00-00 | No | No | Current |
| 16729-174-10 | 16729017410 | 30 in 1 BOTTLE | | | | | Historical |
| 16729-174-17 | 16729017417 | 1000 in 1 BOTTLE | | | | | Historical |