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NDC 00574-4022-35 Bacitracin 500 [USP'U]/g Details
Bacitracin 500 [USP'U]/g
Bacitracin is a OPHTHALMIC OINTMENT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Padagis US LLC. The primary component is BACITRACIN.
MedlinePlus Drug Summary
Ophthalmic bacitracin is used to treat bacterial infections of the eye. Bacitracin is in a class of medications called antibiotics. It works by killing bacteria that cause infections.
Related Packages: 00574-4022-35Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bacitracin Ophthalmic
Product Information
| NDC | 00574-4022 |
|---|---|
| Product ID | 0574-4022_6b07949f-2ca2-4a23-a0a4-a36abd1f565c |
| Associated GPIs | 86101005004205 |
| GCN Sequence Number | 007990 |
| GCN Sequence Number Description | bacitracin OINT. (G) 500 UNIT/G OPHTHALMIC |
| HIC3 | Q6W |
| HIC3 Description | OPHTHALMIC ANTIBIOTICS |
| GCN | 33641 |
| HICL Sequence Number | 004047 |
| HICL Sequence Number Description | BACITRACIN |
| Brand/Generic | Generic |
| Proprietary Name | Bacitracin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Bacitracin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | OINTMENT |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | [USP'U]/g |
| Substance Name | BACITRACIN |
| Labeler Name | Padagis US LLC |
| Pharmaceutical Class | Decreased Cell Wall Synthesis & Repair [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA061212 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00574-4022-35 (00574402235)
| NDC Package Code | 0574-4022-35 |
|---|---|
| Billing NDC | 00574402235 |
| Package | 1 TUBE in 1 CARTON (0574-4022-35) / 3.5 g in 1 TUBE |
| Marketing Start Date | 2014-03-10 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 30.1692 |
| Pricing Unit | GM |
| Effective Date | 2023-12-20 |
| NDC Description | BACITRACIN 500 UNIT/GM OPHTHALMIC OINTMENT |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 6ed2f2bd-9d2f-46af-a44c-95a02ca034de Details
DESCRIPTION:
CLINICAL PHARMACOLOGY:
INDICATIONS AND USAGE:
CONTRAINDICATIONS:
PRECAUTIONS:
Bacitracin ophthalmic ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic. The prolonged use of antibiotic containing preparations may result in overgrowth of nonsusceptible organisms particularly fungi. If new infections develop during treatment appropriate antibiotic or chemotherapy should be instituted.
ADVERSE REACTIONS:
Bacitracin has such a low incidence of allergenicity that for all practical purposes side reactions are practically non-existent. However, if such reaction should occur, therapy should be discontinued.
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DOSAGE AND ADMINISTRATION:
The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye.
HOW SUPPLIED:
SPL UNCLASSIFIED SECTION
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3.5 g Carton
INGREDIENTS AND APPEARANCE
| BACITRACIN
bacitracin ointment |
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| Labeler - Padagis US LLC (967694121) |