Mupirocin

Product NDC
16714-055
11-digit product format
167140055
Labeler code
16714
Product ID
16714-055_4f1f71b7-a564-8070-e063-6394a90a52ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mupirocin calcium
Dosage form
CREAM
Route
TOPICAL
Labeler
NORTHSTAR RX LLC
Application
ANDA207116
Marketing category
ANDA
Marketing start
2020-11-25
Substance
MUPIROCIN CALCIUM
Active strength
20 mg/g
Pharmacologic classes
RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207116-001MUPIROCINMUPIROCIN CALCIUMEQ 2% BASECREAM / TOPICALAB2020-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207116-001AB

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
2026-02-19 14:30 UTC2026-02A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-274b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207116-001MUPIROCINEQ 2% BASECREAM / TOPICALAB2020-04-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207116-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207116-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207116-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207116-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207116-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207116-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207116-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207116-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207116-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207116-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207116-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207116-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207116-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207116-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207116-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207116-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207116-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207116-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207116-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207116-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207116-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207116-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207116-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207116-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207116-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207116-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207116-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207116-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207116-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207116-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207116-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207116-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207116-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207116-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207116-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207116-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207116-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Mupirocin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MUPIROCIN CALCIUM20 mg/g

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
6f1c0789-4a3b-473a-96d6-0c479ee32d36Available 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
16714-055-01Mupirocin15 g in 1 TUBECREAM153
16714-055-01Mupirocin1 in 1 CARTONCREAM13
16714-055-02Mupirocin30 g in 1 TUBECREAM303
16714-055-02Mupirocin1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-055-01GM - Gram16714-055eee80345-d9a6-4cd6-916a-18498ffddbe712021-03-02
16714-055-02GM - Gram16714-05500031e9f-2605-40a8-80c4-3ab40cd6382b12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-055MUPIROCIN (MUPIROCIN CALCIUM) CREAM [NORTHSTAR RX LLC]1Current NDC, Legacy NDC, 4 package rows20210114_6f1c0789-4a3b-473a-96d6-0c479ee32d36.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MupirocinMUPIROCIN CALCIUMREMEDYREPACK INC.9a1be092-6fe8-4b7c-a668-e584783f888b2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207116
application number: ANDA207116
MupirocinMUPIROCIN CALCIUMSun Pharmaceutical Industries, Inc.6719ffba-3430-4fa9-b65b-c5c195ee1b352026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207116
application number: ANDA207116
MupirocinMUPIROCIN CALCIUMNORTHSTAR RX LLC6f1c0789-4a3b-473a-96d6-0c479ee32d362026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207116
application number: ANDA207116
ndc (product): 16714-055

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311877mupirocin 2 % Topical CreamPSN6f1c0789-4a3b-473a-96d6-0c479ee32d363
311877mupirocin 20 MG/ML Topical CreamSCD6f1c0789-4a3b-473a-96d6-0c479ee32d363
311877mupirocin (as mupirocin calcium) 20 MG/ML Topical CreamSY6f1c0789-4a3b-473a-96d6-0c479ee32d363
311877mupirocin 2 % Topical CreamSY6f1c0789-4a3b-473a-96d6-0c479ee32d363

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-055-01167140055011 TUBE in 1 CARTON (16714-055-01) / 15 g in 1 TUBE1 tube2020-11-250000-00-00NoNoCurrent
16714-055-02167140055021 TUBE in 1 CARTON (16714-055-02) / 30 g in 1 TUBE1 tube2020-11-250000-00-00NoNoCurrent