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NDC 54092-0513-02 Intuniv 1 mg/1 Details
Intuniv 1 mg/1
Intuniv is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is GUANFACINE HYDROCHLORIDE.
Product Information
| NDC | 54092-0513 |
|---|---|
| Product ID | 54092-513_1eef54c1-5c87-44f1-bab6-42f72d4fe0be |
| Associated GPIs | 61353030107520 |
| GCN Sequence Number | 065570 |
| GCN Sequence Number Description | guanfacine HCl TAB ER 24H 1 MG ORAL |
| HIC3 | H8M |
| HIC3 Description | TX FOR ADHD - SELECTIVE ALPHA-2 RECEPTOR AGONIST |
| GCN | 27576 |
| HICL Sequence Number | 000120 |
| HICL Sequence Number Description | GUANFACINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Intuniv |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | guanfacine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/1 |
| Substance Name | GUANFACINE HYDROCHLORIDE |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Pharmaceutical Class | Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022037 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 54092-0513-02 (54092051302)
| NDC Package Code | 54092-513-02 |
|---|---|
| Billing NDC | 54092051302 |
| Package | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-513-02) |
| Marketing Start Date | 2009-09-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |