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NDC 50991-0136-16 Endal 10; 1.25 mg/5mL; mg/5mL Details
Endal 10; 1.25 mg/5mL; mg/5mL
Endal is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Poly Pharmaceuticals, Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE.
Product Information
| NDC | 50991-0136 |
|---|---|
| Product ID | 50991-136_fc5401e2-ed66-72e7-e053-6294a90a81f3 |
| Associated GPIs | |
| GCN Sequence Number | 042840 |
| GCN Sequence Number Description | dextromethorphan/triprolidine SOLUTION 10-1.25/5 ORAL |
| HIC3 | B4E |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-1ST GEN ANTIHISTAMINE COMB. |
| GCN | 92562 |
| HICL Sequence Number | 007899 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/TRIPROLIDINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Endal |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Triprolidine HCl, Dextromethorphan HBr |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 10; 1.25 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE |
| Labeler Name | Poly Pharmaceuticals, Inc. |
| Pharmaceutical Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50991-0136-16 (50991013616)
| NDC Package Code | 50991-136-16 |
|---|---|
| Billing NDC | 50991013616 |
| Package | 473 mL in 1 BOTTLE (50991-136-16) |
| Marketing Start Date | 2023-05-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |