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NDC 55150-0166-13 Sildenafil 10 mg/12.5mL Details
Sildenafil 10 mg/12.5mL
Sildenafil is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eugia US LLC. The primary component is SILDENAFIL CITRATE.
Product Information
| NDC | 55150-0166 |
|---|---|
| Product ID | 55150-166_c6f23ad9-ca87-47a3-8d85-dfc334e5a91b |
| Associated GPIs | 40143060102020 |
| GCN Sequence Number | 066092 |
| GCN Sequence Number Description | sildenafil citrate VIAL 10 MG/12.5 INTRAVEN |
| HIC3 | B1D |
| HIC3 Description | PULM.ANTI-HTN,SEL.C-GMP PHOSPHODIESTERASE T5 INHIB |
| GCN | 28273 |
| HICL Sequence Number | 018084 |
| HICL Sequence Number Description | SILDENAFIL CITRATE |
| Brand/Generic | Generic |
| Proprietary Name | Sildenafil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sildenafil Citrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/12.5mL |
| Substance Name | SILDENAFIL CITRATE |
| Labeler Name | Eugia US LLC |
| Pharmaceutical Class | Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203988 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55150-0166-13 (55150016613)
| NDC Package Code | 55150-166-13 |
|---|---|
| Billing NDC | 55150016613 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-166-13) / 12.5 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2015-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |