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NDC 63304-0926-05 Guanfacine 3 mg/1 Details
Guanfacine 3 mg/1
Guanfacine is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc. The primary component is GUANFACINE HYDROCHLORIDE.
Product Information
NDC | 63304-0926 |
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Product ID | 63304-926_ccff8408-b71e-434b-96ce-42827aa6c362 |
Associated GPIs | 61353030107540 |
GCN Sequence Number | 065573 |
GCN Sequence Number Description | guanfacine HCl TAB ER 24H 3 MG ORAL |
HIC3 | H8M |
HIC3 Description | TX FOR ADHD - SELECTIVE ALPHA-2 RECEPTOR AGONIST |
GCN | 27579 |
HICL Sequence Number | 000120 |
HICL Sequence Number Description | GUANFACINE HCL |
Brand/Generic | Generic |
Proprietary Name | Guanfacine |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Guanfacine |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, EXTENDED RELEASE |
Route | ORAL |
Active Ingredient Strength | 3 |
Active Ingredient Units | mg/1 |
Substance Name | GUANFACINE HYDROCHLORIDE |
Labeler Name | Sun Pharmaceutical Industries, Inc |
Pharmaceutical Class | Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA205689 |
Listing Certified Through | 2024-12-31 |
Package
NDC 63304-0926-05 (63304092605)
NDC Package Code | 63304-926-05 |
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Billing NDC | 63304092605 |
Package | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-926-05) |
Marketing Start Date | 2018-08-17 |
NDC Exclude Flag | N |
Pricing Information | N/A |