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NDC 00517-0381-05 PROVAYBLUE 5 mg/mL Details
PROVAYBLUE 5 mg/mL
PROVAYBLUE is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by American Regent, Inc.. The primary component is METHYLENE BLUE.
Product Information
| NDC | 00517-0381 |
|---|---|
| Product ID | 0517-0381_be3445b6-dd6e-4e3c-8bd8-edc0d1cf5d19 |
| Associated GPIs | 93000050002030 |
| GCN Sequence Number | 083231 |
| GCN Sequence Number Description | methylene blue VIAL 50 MG/10ML INTRAVEN |
| HIC3 | C8B |
| HIC3 Description | ACID AND ALKALI POISON ANTIDOTES |
| GCN | 52132 |
| HICL Sequence Number | 001110 |
| HICL Sequence Number Description | METHYLENE BLUE |
| Brand/Generic | Brand |
| Proprietary Name | PROVAYBLUE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | methylene blue |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | METHYLENE BLUE |
| Labeler Name | American Regent, Inc. |
| Pharmaceutical Class | Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA204630 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00517-0381-05 (00517038105)
| NDC Package Code | 0517-0381-05 |
|---|---|
| Billing NDC | 00517038105 |
| Package | 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-0381-05) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-0381-01) |
| Marketing Start Date | 2021-12-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |