FDA.reportPublic FDA data

MUPIROCIN

Product NDC
21922-073
11-digit product format
219220073
Labeler code
21922
Product ID
21922-073_d03736e8-6e52-4e41-81b4-1ef58ef9e90c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MUPIROCIN
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA217943
Marketing category
ANDA
Marketing start
2025-05-16
Substance
MUPIROCIN
Active strength
20 mg/g
Pharmacologic classes
RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MUPIROCIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MUPIROCIN20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD0GX863OA5
Rxcui106346

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f8c312-f164-6104-0de4-ec45484840e3Product name220260304
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0c2e0212-b823-4ce8-611e-853ac2cac1b2Product name420230327
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3db2f5c1-f78c-f062-515c-4827e36c2518Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f74f326b-f453-01a0-e7e7-ce5ea9475503Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-073-04MUPIROCIN1 in 1 CARTONOINTMENT14
21922-073-04MUPIROCIN15 g in 1 TUBEOINTMENT154
21922-073-05MUPIROCIN30 g in 1 TUBEOINTMENT304
21922-073-05MUPIROCIN1 in 1 CARTONOINTMENT14
21922-073-25MUPIROCIN22 g in 1 TUBEOINTMENT224
21922-073-25MUPIROCIN1 in 1 CARTONOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-073-04GM - Gram21922-073bdd0d73d-c135-421b-a53f-634beff48cd212025-07-08
21922-073-25GM - Gram21922-0731e2e9d47-399b-4f8d-b01d-635265aa032712025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-073MUPIROCIN (MUPIROCIN) OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED]3Current NDC, 6 package rows20250523_95c302b8-affa-431a-9b89-0506f5a098e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSN95c302b8-affa-431a-9b89-0506f5a098e64
106346mupirocin 0.02 MG/MG Topical OintmentSCD95c302b8-affa-431a-9b89-0506f5a098e64
106346mupirocin 2 % Topical OintmentSY95c302b8-affa-431a-9b89-0506f5a098e64
106346mupirocin 20 MG per GM Topical OintmentSY95c302b8-affa-431a-9b89-0506f5a098e64
106346mupirocin 2 % Topical OintmentPSN49eb7289-c44d-75e1-e063-6294a90a22831
106346mupirocin 0.02 MG/MG Topical OintmentSCD49eb7289-c44d-75e1-e063-6294a90a22831
106346mupirocin 2 % Topical OintmentSY49eb7289-c44d-75e1-e063-6294a90a22831
106346mupirocin 20 MG per GM Topical OintmentSY49eb7289-c44d-75e1-e063-6294a90a22831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-073-04219220073041 TUBE in 1 CARTON (21922-073-04) / 15 g in 1 TUBE1 tube2025-05-16NoNoCurrent
21922-073-05219220073051 TUBE in 1 CARTON (21922-073-05) / 30 g in 1 TUBE1 tube2025-05-16NoNoCurrent
21922-073-25219220073251 TUBE in 1 CARTON (21922-073-25) / 22 g in 1 TUBE1 tube2025-05-16NoNoCurrent