Guanfacine Hydrochloride
- Product NDC
- 29300-459
- 11-digit product format
- 293000459
- Labeler code
- 29300
- Product ID
- 29300-459_9df9e7f8-a9b3-4919-94f9-07c81ff7c8b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA214689
- Marketing category
- ANDA
- Marketing start
- 2021-03-03
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guanfacine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUANFACINE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 30OMY4G3MK |
| Rxcui | 197745, 197746 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-459-01 | Guanfacine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-459 | GUANFACINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20210331_14146031-8d56-469b-8de8-fe3cf1712e78.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 |
|---|
| 29300-459-01 | 29300045901 | 100 TABLET in 1 BOTTLE (29300-459-01) | 100 tablet | 2021-04-05 | 0000-00-00 | No | No | Current |