Guanfacine
- Product NDC
- 60429-963
- 11-digit product format
- 604290963
- Labeler code
- 60429
- Product ID
- 60429-963_36f0bfe4-416a-32ff-e063-6394a90a6930
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA201408
- Marketing category
- ANDA
- Marketing start
- 2015-06-02
- Marketing end
- 2026-10-31
- Substance
- GUANFACINE
- Active strength
- 4 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
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUANFACINE | 4 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 30OMY4G3MK |
| Rxcui | 862006, 862013, 862019, 862025 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 44b80df7-57c9-56d4-c87a-f0d57d327460 | Product name | 9 | 20260127 |
| 4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0 | Product name | 3 | 20230308 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60429-963-01 | GuanfacineExtended-Release | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60429-963-01 | EA - Each | 60429-963 | cc2aacb1-7913-4e22-ae2f-ff5520d900bc | 1 | 2017-11-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 862006 | guanFACINE 1 MG 24HR Extended Release Oral Tablet | PSN | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862013 | guanFACINE 2 MG 24HR Extended Release Oral Tablet | PSN | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862019 | guanFACINE 3 MG 24HR Extended Release Oral Tablet | PSN | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862025 | guanFACINE 4 MG 24HR Extended Release Oral Tablet | PSN | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862006 | 24 HR guanfacine 1 MG Extended Release Oral Tablet | SCD | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862013 | 24 HR guanfacine 2 MG Extended Release Oral Tablet | SCD | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862019 | 24 HR guanfacine 3 MG Extended Release Oral Tablet | SCD | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862025 | 24 HR guanfacine 4 MG Extended Release Oral Tablet | SCD | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862006 | guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet | SY | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862006 | guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet | SY | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862013 | guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet | SY | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862013 | guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet | SY | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862019 | guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral Tablet | SY | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862019 | guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral Tablet | SY | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862025 | guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet | SY | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
| 862025 | guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral Tablet | SY | 6006df06-0448-462d-b81e-7add50a6d71b | 12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60429-963-01 | 60429096301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60429-963-01) | 2017-10-06 | 0000-00-00 | No | No | Current |