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NDC 50382-0006-21 Bacitracin Zinc 500 [iU]/g Details
Bacitracin Zinc 500 [iU]/g
Bacitracin Zinc is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Galentic Pharma (India) Private Limited. The primary component is BACITRACIN ZINC.
Product Information
NDC | 50382-0006 |
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Product ID | 50382-006_ee22a881-536d-ea69-e053-2a95a90a33fe |
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 | Bacitracin Zinc |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Bacitracin Zinc |
Product Type | HUMAN OTC DRUG |
Dosage Form | OINTMENT |
Route | TOPICAL |
Active Ingredient Strength | 500 |
Active Ingredient Units | [iU]/g |
Substance Name | BACITRACIN ZINC |
Labeler Name | Galentic Pharma (India) Private Limited |
Pharmaceutical Class | Decreased Cell Wall Synthesis & Repair [PE] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part333B |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 50382-0006-21 (50382000621)
NDC Package Code | 50382-006-21 |
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Billing NDC | 50382000621 |
Package | 25 PACKET in 1 CARTON (50382-006-21) / .9 g in 1 PACKET |
Marketing Start Date | 2013-08-07 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 4a92eec1-eb71-4aef-b6fa-b7257ecc0984 Details
• WARNINGS
• DIRECTIONS
• OTHER INFORMATION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
INGREDIENTS AND APPEARANCE
BACITRACIN ZINC
bacitracin zinc ointment |
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Labeler - Galentic Pharma (India) Private Limited (915110464) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Galentic Pharma (India) Private Limited | 650970176 | manufacture(50382-006) , pack(50382-006) , sterilize(50382-006) , analysis(50382-006) |
Revised: 11/2022
Document Id: ee22a881-536d-ea69-e053-2a95a90a33fe
Set id: 4a92eec1-eb71-4aef-b6fa-b7257ecc0984
Version: 5
Effective Time: 20221123