Amitriptyline Hydrochloride
- Product NDC
- 21695-252
- 11-digit product format
- 216950252
- Labeler code
- 21695
- Product ID
- 21695-252_a2368fd3-124e-476d-a8db-9c45e7423562
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- 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
- 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 |
|---|
| 21695-252-30 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 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 [REBEL DISTRIBUTORS CORP.] | 1 | |
| AMITRIPTYLINE | ACTIVE MOIETY | 1806D8D52K | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-252 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | Legacy NDC, 1 package rows | 20100312_d441d278-2c54-4a22-83a3-4627d49aaae4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-252-30 | 21695025230 | 30 in 1 BOTTLE | Historical |