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NDC 58809-0999-02 VANACOF 12.5; 1; 30 mg/5mL; mg/5mL; mg/5mL Details
VANACOF 12.5; 1; 30 mg/5mL; mg/5mL; mg/5mL
VANACOF is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by GM Pharmaceuticals, INC. The primary component is CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE.
Product Information
| NDC | 58809-0999 |
|---|---|
| Product ID | 58809-999_02e794d3-e6b6-8ee7-e063-6394a90ab69d |
| Associated GPIs | 43995803630920 |
| GCN Sequence Number | 064077 |
| GCN Sequence Number Description | dexchlorphenir/pse/chlophedian LIQUID 1-30-12.5 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 99788 |
| HICL Sequence Number | 035643 |
| HICL Sequence Number Description | DEXCHLORPHENIRAMINE MALEATE/PSEUDOEPHEDRINE/CHLOPHEDIANOL |
| Brand/Generic | Brand |
| Proprietary Name | VANACOF |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, and Pseudoephedrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 12.5; 1; 30 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | GM Pharmaceuticals, INC |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58809-0999-02 (58809099902)
| NDC Package Code | 58809-999-02 |
|---|---|
| Billing NDC | 58809099902 |
| Package | 12 BOTTLE in 1 TRAY (58809-999-02) / 15 mL in 1 BOTTLE |
| Marketing Start Date | 2008-04-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |