Guanfacine
- Product NDC
- 70518-4539
- 11-digit product format
- 705184539
- Labeler code
- 70518
- Product ID
- 70518-4539_4858f0eb-08c7-1a50-e063-6394a90a4c5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA219033
- Marketing category
- ANDA
- Marketing start
- 2025-12-23
- Substance
- GUANFACINE HYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guanfacine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUANFACINE HYDROCHLORIDE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PML56A160O |
| Rxcui | 862006 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4539-0 | Guanfacine | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4539-0 | 70518453900 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4539-0) | 2025-12-23 | No | No | Current |