Mupirocin

Product NDC
21922-029
11-digit product format
219220029
Labeler code
21922
Product ID
21922-029_245cc065-74d4-4232-bd0c-f1854a2559c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
CREAM
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA213076
Marketing category
ANDA
Marketing start
2021-09-02
Substance
MUPIROCIN CALCIUM
Active strength
2 g/100g
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
A213076-001MUPIROCINMUPIROCIN CALCIUMEQ 2% BASECREAM / TOPICALAB2021-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213076-001AB

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 06:07:402026-07A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-314b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213076-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2021-08-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213076-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213076-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213076-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213076-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213076-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213076-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213076-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213076-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213076-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213076-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213076-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213076-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213076-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213076-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213076-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213076-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213076-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213076-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213076-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213076-001AB1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213076-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213076-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213076-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213076-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213076-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213076-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213076-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213076-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A213076-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213076-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213076-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213076-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213076-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213076-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MUPIROCIN CALCIUM2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RG38I2P540Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311877Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb085bdf-e371-6e8a-e053-2995a90ae358Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f8c312-f164-6104-0de4-ec45484840e3Product name220260304
0c2e0212-b823-4ce8-611e-853ac2cac1b2Product name420230327
3db2f5c1-f78c-f062-515c-4827e36c2518Product name120140508
f74f326b-f453-01a0-e7e7-ce5ea9475503Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-029-04Mupirocin1 in 1 CARTONCREAM13
21922-029-04Mupirocin15 g in 1 TUBECREAM153
21922-029-05Mupirocin30 g in 1 TUBECREAM303
21922-029-05Mupirocin1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-029-04GM - Gram21922-029c04be48e-3c68-4734-b52b-5d47f564f7ca12021-10-08
21922-029-05GM - Gram21922-029176e71de-f853-469f-9b8e-4720cd7f199b12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-029MUPIROCIN CREAM [ENCUBE ETHICALS PRIVATE LIMITED]2Current NDC, Legacy NDC, 4 package rows20231109_cb085bdf-e371-6e8a-e053-2995a90ae358.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
MupirocinMUPIROCINSportpharm LLCe250adda-52a5-486f-a43d-2cc486dbe2a82026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213076
application number: ANDA213076
MupirocinMUPIROCINEncube Ethicals, Inc.cb085bdf-e371-6e8a-e053-2995a90ae3582025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213076
application number: ANDA213076
ndc (product): 21922-029

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311877mupirocin 2 % Topical CreamPSNcb085bdf-e371-6e8a-e053-2995a90ae3583
311877mupirocin 20 MG/ML Topical CreamSCDcb085bdf-e371-6e8a-e053-2995a90ae3583
311877mupirocin (as mupirocin calcium) 20 MG/ML Topical CreamSYcb085bdf-e371-6e8a-e053-2995a90ae3583
311877mupirocin 2 % Topical CreamSYcb085bdf-e371-6e8a-e053-2995a90ae3583
311877mupirocin 2 % Topical CreamPSNe250adda-52a5-486f-a43d-2cc486dbe2a81
311877mupirocin 20 MG/ML Topical CreamSCDe250adda-52a5-486f-a43d-2cc486dbe2a81
311877mupirocin (as mupirocin calcium) 20 MG/ML Topical CreamSYe250adda-52a5-486f-a43d-2cc486dbe2a81
311877mupirocin 2 % Topical CreamSYe250adda-52a5-486f-a43d-2cc486dbe2a81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21922-029-04219220029041 TUBE in 1 CARTON (21922-029-04) / 15 g in 1 TUBE1 tube2021-09-020000-00-00NoNoCurrent
21922-029-05219220029051 TUBE in 1 CARTON (21922-029-05) / 30 g in 1 TUBE1 tube2021-09-020000-00-00NoNoCurrent