Guanfacine Hydrochloride
- Product NDC
- 70518-3516
- 11-digit product format
- 705183516
- Labeler code
- 70518
- Product ID
- 70518-3516_4f1ff1f7-c445-fc56-e063-6294a90a1d7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA214689
- Marketing category
- ANDA
- Marketing start
- 2022-09-13
- Substance
- GUANFACINE
- Active strength
- 2 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 Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUANFACINE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 30OMY4G3MK |
| Rxcui | 197746 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3516-0 | Guanfacine Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3516 | GUANFACINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250504_1b1063ba-fee3-4540-9139-db4b915f82e2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3516-0 | 70518351600 | 30 TABLET in 1 BLISTER PACK (70518-3516-0) | 30 tablet | 2022-09-13 | 0000-00-00 | No | No | Current |