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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217943-001MUPIROCINMUPIROCIN2%OINTMENT / TOPICALAB2025-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217943-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217943-001MUPIROCIN2%OINTMENT / TOPICALAB2025-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217943-001MUPIROCIN2%OINTMENT / TOPICALAB2025-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217943-001MUPIROCIN2%OINTMENT / TOPICALAB2025-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A217943-001MUPIROCIN2%OINTMENT / TOPICALAB2025-05-136a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217943-001MUPIROCIN2%OINTMENT / TOPICALAB2025-05-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217943-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217943-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217943-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217943-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217943-001AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D0GX863OA5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
106346Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
95c302b8-affa-431a-9b89-0506f5a098e6Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUPIROCINMUPIROCINRedpharm Drug49eb7289-c44d-75e1-e063-6294a90a22832026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217943
application number: ANDA217943
MUPIROCINMUPIROCINEncube Ethicals, Inc.95c302b8-affa-431a-9b89-0506f5a098e62025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217943
application number: ANDA217943
ndc (product): 21922-073

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