TENEX
- Product NDC
- 67857-705
- 11-digit product format
- 678570705
- Labeler code
- 67857
- Product ID
- 67857-705_1b6fa629-ed24-8a9c-de2a-36bf69ea2e4d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- guanfacine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Promius Pharma, LLC
- Application
- NDA019032
- Marketing category
- NDA
- Marketing start
- 1986-10-27
- Marketing end
- 0000-00-00
- Substance
- GUANFACINE HYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
- 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 |
|---|
| 67857-705-01 | TENEX | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 7 |
| 67857-705-05 | TENEX | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GUANFACINE HYDROCHLORIDE | ACTIVE INGREDIENT | PML56A160O | TENEX (GUANFACINE HYDROCHLORIDE) TABLET [PROMIUS PHARMA, LLC] | 7 | |
| GUANFACINE | ACTIVE MOIETY | 30OMY4G3MK | TENEX (GUANFACINE HYDROCHLORIDE) TABLET [PROMIUS PHARMA, LLC] | 7 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TENEX (GUANFACINE HYDROCHLORIDE) TABLET [PROMIUS PHARMA, LLC] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TENEX (GUANFACINE HYDROCHLORIDE) TABLET [PROMIUS PHARMA, LLC] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TENEX (GUANFACINE HYDROCHLORIDE) TABLET [PROMIUS PHARMA, LLC] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | TENEX (GUANFACINE HYDROCHLORIDE) TABLET [PROMIUS PHARMA, LLC] | 7 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | TENEX (GUANFACINE HYDROCHLORIDE) TABLET [PROMIUS PHARMA, LLC] | 7 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | TENEX (GUANFACINE HYDROCHLORIDE) TABLET [PROMIUS PHARMA, LLC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67857-705 | TENEX (GUANFACINE HYDROCHLORIDE) TABLET [PROMIUS PHARMA, LLC] | 7 | Legacy NDC, 2 package rows | 20130726_886e050c-dd22-4f35-ac3b-243f091125c3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 67857-705-01 | 67857070501 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 67857-705-05 | 67857070505 | 500 in 1 BOTTLE, PLASTIC | Historical |