Guanfacine
- Product NDC
- 71205-946
- 11-digit product format
- 712050946
- Labeler code
- 71205
- Product ID
- 71205-946_6de48883-f40b-4aef-83d4-6acb86c1b11e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA201408
- Marketing category
- ANDA
- Marketing start
- 2017-07-07
- Substance
- GUANFACINE
- Active strength
- 3 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
- Brand name suffix
- Extended-Release
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUANFACINE | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 30OMY4G3MK |
| 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 |
|---|
| 71205-946-00 | GuanfacineExtended-Release | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 2 |
| 71205-946-30 | GuanfacineExtended-Release | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 2 |
| 71205-946-55 | GuanfacineExtended-Release | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 2 |
| 71205-946-60 | GuanfacineExtended-Release | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 2 |
| 71205-946-90 | GuanfacineExtended-Release | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-946 | GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP] | 2 | Current NDC, Legacy NDC, 5 package rows | 20220426_6460ad33-4feb-4a4d-9958-501084046389.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-946-00 | 71205094600 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-946-00) | 2020-11-19 | 0000-00-00 | No | No | Current |
| 71205-946-30 | 71205094630 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-946-30) | 2020-11-19 | 0000-00-00 | No | No | Current |
| 71205-946-55 | 71205094655 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-946-55) | 2020-11-19 | 0000-00-00 | No | No | Current |
| 71205-946-60 | 71205094660 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-946-60) | 2020-11-19 | 0000-00-00 | No | No | Current |
| 71205-946-90 | 71205094690 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-946-90) | 2020-11-19 | 0000-00-00 | No | No | Current |