Guanfacine
- Product NDC
- 70518-4333
- 11-digit product format
- 705184333
- Labeler code
- 70518
- Product ID
- 70518-4333_4030552e-44d1-d71c-e063-6394a90ad1de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA217293
- Marketing category
- ANDA
- Marketing start
- 2025-04-25
- 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
- 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PML56A160O |
| Rxcui | 197745 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4333-0 | Guanfacine | 30 in 1 BLISTER PACK | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4333 | GUANFACINE (GUANFACINE) TABLET [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20250427_04a3bd2d-9a9c-43e8-a0e2-280e02265f16.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4333-0 | 70518433300 | 30 TABLET in 1 BLISTER PACK (70518-4333-0) | 30 tablet | 2025-04-25 | No | No | Historical |