GUANFACINE HYDROCHLORIDE
- Product NDC
- 62135-727
- 11-digit product format
- 621350727
- Labeler code
- 62135
- Product ID
- 62135-727_459cdf6c-19fa-c506-e063-6394a90a7393
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- guanfacine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA216399
- Marketing category
- ANDA
- Marketing start
- 2022-09-01
- 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 HYDROCHLORIDE
- 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, 197746 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-727-90 | GUANFACINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-727 | GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [CHARTWELL RX, LLC] | 2 | Current NDC, 1 package rows | 20241030_fa7ae501-ee34-4e50-9052-7952e36bbd0e.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 |
|---|
| 62135-727-90 | 62135072790 | 90 TABLET in 1 BOTTLE (62135-727-90) | 90 tablet | 2023-07-12 | No | No | Historical |