GUANFACINE
- Product NDC
- 72888-225
- 11-digit product format
- 728880225
- Labeler code
- 72888
- Product ID
- 72888-225_3383419f-2181-88f4-e063-6394a90a38bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GUANFACINE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Advagen Pharma Limited
- Application
- ANDA219689
- Marketing category
- ANDA
- Marketing start
- 2025-04-15
- Substance
- GUANFACINE HYDROCHLORIDE
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUANFACINE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PML56A160O |
| Rxcui | 862006, 862013, 862019, 862025 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72888-225-00 | GUANFACINE | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 3 |
| 72888-225-01 | GUANFACINE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 3 |
| 72888-225-05 | GUANFACINE | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 3 |
| 72888-225-30 | GUANFACINE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72888-225 | GUANFACINE TABLET, EXTENDED RELEASE [ADVAGEN PHARMA LIMITED] | 3 | Current NDC, 4 package rows | 20250426_e16beec7-9acd-4cd1-be5c-b666ad7d2430.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72888-225-00 | 72888022500 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-225-00) | 2025-04-15 | No | No | Current |
| 72888-225-01 | 72888022501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-225-01) | 2025-04-15 | No | No | Current |
| 72888-225-05 | 72888022505 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-225-05) | 2025-04-15 | No | No | Current |
| 72888-225-30 | 72888022530 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-225-30) | 2025-04-15 | No | No | Current |