GUANFACINE
- Product NDC
- 50090-7644
- 11-digit product format
- 500907644
- Labeler code
- 50090
- Product ID
- 50090-7644_0db3ff09-e75b-4a2b-a0bf-1a9459b917a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GUANFACINE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA217269
- Marketing category
- ANDA
- Marketing start
- 2023-08-08
- Substance
- GUANFACINE HYDROCHLORIDE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GUANFACINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUANFACINE HYDROCHLORIDE | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PML56A160O |
| Rxcui | 862019 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7644-0 | GUANFACINE | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7644-0 | 50090764400 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7644-0) | 2025-08-28 | No | No | Historical |