Double Antibiotic

Product NDC
0168-0021
11-digit product format
001680021
Labeler code
0168
Product ID
0168-0021_443a7f87-7fdc-4c44-aad9-f7d8441e7f2a
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-01-06
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500 [USP'U]/g; [USP'U]/g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0021-09EA - Each0168-002153fd61b0-6893-4b1f-ae10-61d1bb422c9812012-07-24
0168-0021-31GM - Gram0168-002176f30bd5-b2a6-474d-a05e-824eda21c0e112012-07-24
0168-0021-35GM - Gram0168-0021ff516210-b74f-4ed5-8d43-a37d6e6164f112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESDOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESDOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESBACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [H.J. HARKINS COMPANY, INC.]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4DOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4DOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [H.J. HARKINS COMPANY, INC.]1
BacitracinACTIVE MOIETY58H6RWO52IDOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
BacitracinACTIVE MOIETY58H6RWO52IDOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
BacitracinACTIVE MOIETY58H6RWO52IBACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [H.J. HARKINS COMPANY, INC.]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KDOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KDOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KBACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [H.J. HARKINS COMPANY, INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UDOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UDOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UBACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [H.J. HARKINS COMPANY, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN6b5d9180-ea2f-4bb7-9e88-b596b638cb1d1
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN715b4b25-5341-491f-98dc-dc4eb249d67b1
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD6b5d9180-ea2f-4bb7-9e88-b596b638cb1d1
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD715b4b25-5341-491f-98dc-dc4eb249d67b1
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY6b5d9180-ea2f-4bb7-9e88-b596b638cb1d1
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY715b4b25-5341-491f-98dc-dc4eb249d67b1