Guanfacine
- Product NDC
- 68151-0623
- 11-digit product format
- 681510623
- Labeler code
- 68151
- Product ID
- 68151-0623_0b490301-5cb7-4a3a-9d34-f1bb1ec743a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- ANDA074145
- Marketing category
- ANDA
- Marketing start
- 1995-10-17
- Marketing end
- 0000-00-00
- Substance
- GUANFACINE HYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-0623-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e3bf-f424-e053-dadaa90a57ce | Guanfacine Tablets, USP Revised: July 2014 Rx only 198950-1 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-0623-0 | Guanfacine | 1 in 1 PACKAGE | TABLET | 1 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GUANFACINE HYDROCHLORIDE | ACTIVE INGREDIENT | PML56A160O | GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| GUANFACINE | ACTIVE MOIETY | 30OMY4G3MK | GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-0623 | GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] | 4 | Legacy NDC, 1 package rows | 20170706_adf51bff-fa50-4c72-b69e-a869a6a825fa.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197745 | guanFACINE HCl 1 MG Oral Tablet | PSN | adf51bff-fa50-4c72-b69e-a869a6a825fa | 4 |
| 197745 | guanfacine 1 MG Oral Tablet | SCD | adf51bff-fa50-4c72-b69e-a869a6a825fa | 4 |
| 197745 | guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral Tablet | SY | adf51bff-fa50-4c72-b69e-a869a6a825fa | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-0623-0 | 68151062300 | 1 in 1 PACKAGE | Historical |