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NDC 64950-0359-04 GOPRELTO 40 mg/mL Details
GOPRELTO 40 mg/mL
GOPRELTO is a NASAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Genus Lifesciences Inc.. The primary component is COCAINE HYDROCHLORIDE.
Product Information
| NDC | 64950-0359 |
|---|---|
| Product ID | 64950-359_67539cd8-fe3c-4c30-af97-2b3451654f71 |
| Associated GPIs | 42230020102010 |
| GCN Sequence Number | 078068 |
| GCN Sequence Number Description | cocaine HCl SOLUTION 4 % NASAL |
| HIC3 | Q7A |
| HIC3 Description | NOSE PREPARATIONS, MISCELLANEOUS (RX) |
| GCN | 44324 |
| HICL Sequence Number | 001519 |
| HICL Sequence Number Description | COCAINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | GOPRELTO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | cocaine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | NASAL |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/mL |
| Substance Name | COCAINE HYDROCHLORIDE |
| Labeler Name | Genus Lifesciences Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | CII |
| Marketing Category | NDA |
| Application Number | NDA209963 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64950-0359-04 (64950035904)
| NDC Package Code | 64950-359-04 |
|---|---|
| Billing NDC | 64950035904 |
| Package | 1 BOTTLE, GLASS in 1 CARTON (64950-359-04) / 4 mL in 1 BOTTLE, GLASS |
| Marketing Start Date | 2018-01-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |