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NDC 58552-0335-02 Giltuss TR 29; 390; 10 mg/1; mg/1; mg/1 Details
Giltuss TR 29; 390; 10 mg/1; mg/1; mg/1
Giltuss TR is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
Product Information
NDC | 58552-0335 |
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Product ID | 58552-335_0875bfe3-2938-298f-e063-6394a90a88cd |
Associated GPIs | |
GCN Sequence Number | 085009 |
GCN Sequence Number Description | guaifen/dextromethorphan/PE TABLET 390MG-29MG ORAL |
HIC3 | B4R |
HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
GCN | 54444 |
HICL Sequence Number | 000216 |
HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
Brand/Generic | Brand |
Proprietary Name | Giltuss TR |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Guaifenesin,Dextromethorphan HBr,Phenylephrine HCl |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 29; 390; 10 |
Active Ingredient Units | mg/1; mg/1; mg/1 |
Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
Labeler Name | Gil Pharmaceutical Corp |
Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH DRUG |
Application Number | M012 |
Listing Certified Through | 2024-12-31 |
Package
NDC 58552-0335-02 (58552033502)
NDC Package Code | 58552-335-02 |
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Billing NDC | 58552033502 |
Package | 2 TABLET in 1 BLISTER PACK (58552-335-02) |
Marketing Start Date | 2022-01-07 |
NDC Exclude Flag | N |
Pricing Information | N/A |