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NDC 00517-0125-05 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 | 00517-0125 |
---|---|
Product ID | 0517-0125_be3445b6-dd6e-4e3c-8bd8-edc0d1cf5d19 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
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 00517-0125-05 (00517012505)
NDC Package Code | 0517-0125-05 |
---|---|
Billing NDC | 00517012505 |
Package | 5 AMPULE in 1 CARTON (0517-0125-05) / 2 mL in 1 AMPULE (0517-0125-01) |
Marketing Start Date | 2020-04-08 |
NDC Exclude Flag | N |
Pricing Information | N/A |