Guanfacine ER
- Product NDC
- 72189-597
- 11-digit product format
- 721890597
- Labeler code
- 72189
- Product ID
- 72189-597_286214e2-a65c-f43b-e063-6394a90a33be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine ER
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Direct_rx
- Application
- ANDA217269
- Marketing category
- ANDA
- Marketing start
- 2024-12-03
- 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 ER
- 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 | 862006 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-597-30 | Guanfacine ER | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-597 | GUANFACINE ER TABLET, EXTENDED RELEASE [DIRECT_RX] | 1 | Current NDC, 1 package rows | 20241207_286214e2-a65b-f43b-e063-6394a90a33be.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-597-30 | 72189059730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-597-30) | 2024-12-03 | No | No | Historical |