Guanfacine
- Product NDC
- 70518-3809
- 11-digit product format
- 705183809
- Labeler code
- 70518
- Product ID
- 70518-3809_4236e005-965c-420b-e063-6394a90ac278
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA201408
- Marketing category
- ANDA
- Marketing start
- 2023-07-29
- 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
- Brand name suffix
- Extended-Release
- 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 | 862013 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3809-0 | GuanfacineExtended-Release | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3809 | GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] | 5 | Current NDC, 1 package rows | 20250511_3ec4fed6-cafc-49a0-9540-8d70ac435769.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3809-0 | 70518380900 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3809-0) | 2023-07-29 | No | No | Historical |