astonea

Product NDC
77338-303
11-digit product format
773380303
Labeler code
77338
Product ID
77338-303_1bbae69c-ba20-2fff-e063-6294a90a8232
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-02
Substance
BACITRACIN ZINC
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
astonea
Brand name suffix
First Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES
Rxcui1648110

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-303-52astoneaFirst Aid0.9 g in 1 PACKETOINTMENT0.93
77338-303-53astoneaFirst Aid28.3 g in 1 TUBEOINTMENT28.33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-303ASTONEA FIRST AID (BACITRACIN ZINC) OINTMENT [ASTONEA LABS PRIVATE LIMITED]3Current NDC, Legacy NDC, 2 package rows20240627_de0b2e06-64bc-78f0-e053-2995a90a39a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSNde0b2e06-64bc-78f0-e053-2995a90a39a03
1648110bacitracin 0.5 UNT/MG Topical OintmentSCDde0b2e06-64bc-78f0-e053-2995a90a39a03
1648110bacitracin 500 UNT per GM Topical OintmentSYde0b2e06-64bc-78f0-e053-2995a90a39a03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-303-5277338030352.9 g in 1 PACKET (77338-303-52) 2022-05-020000-00-00NoNoCurrent
77338-303-537733803035328.3 g in 1 TUBE (77338-303-53) 28.3 g2022-05-020000-00-00NoNoCurrent