Imipramine Hydrochloride
- Product NDC
- 64125-133
- 11-digit product format
- 641250133
- Labeler code
- 64125
- Product ID
- 64125-133_9a23d0f8-191b-4a68-b25a-627e22571373
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Imipramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Excellium Pharmaceutical, Inc
- Application
- ANDA040903
- Marketing category
- ANDA
- Marketing start
- 2012-11-01
- Marketing end
- 0000-00-00
- Substance
- IMIPRAMINE HYDROCHLORIDE
- Active strength
- 10 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 |
|---|
| 64125-133-01 | Imipramine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 64125-133-10 | Imipramine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IMIPRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | BKE5Q1J60U | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| IMIPRAMINE | ACTIVE MOIETY | OGG85SX4E4 | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64125-133 | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC] | 1 | Legacy NDC, 2 package rows | 20121108_26454960-2551-4301-b2dc-1b9eab4cbf19.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 64125-133-01 | 64125013301 | 100 in 1 BOTTLE | Historical |
| 64125-133-10 | 64125013310 | 1000 in 1 BOTTLE | Historical |