Home NDC 68462-564 Mupirocin
Product NDC 68462-564
11-digit product format 684620564
Labeler code 68462
Product ID 68462-564_4d903d30-cc63-4585-bb9c-70fe90da514c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mupirocin
Dosage form CREAM
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA201587
Marketing category ANDA
Marketing start 2013-01-24
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201587-001 MUPIROCIN MUPIROCIN CALCIUM EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201587-001 AB
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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL RS 2013-01-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL RS 2013-01-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL RS 2013-01-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL RS 2013-01-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201587-001 MUPIROCIN EQ 2% BASE CREAM / TOPICAL AB RS 2013-01-24 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Mupirocin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MUPIROCIN CALCIUM 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RG38I2P540 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311877 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-564-17 Mupirocin 15 g in 1 TUBE CREAM 15 8 68462-564-35 Mupirocin 30 g in 1 TUBE CREAM 30 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MUPIROCIN CALCIUM ACTIVE INGREDIENT RG38I2P540 MUPIROCIN CREAM [GLENMARK PHARMACEUTICALS INC., USA] 4 MUPIROCIN ACTIVE MOIETY D0GX863OA5 MUPIROCIN CREAM [GLENMARK PHARMACEUTICALS INC., USA] 4 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH MUPIROCIN CREAM [GLENMARK PHARMACEUTICALS INC., USA] 4 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 MUPIROCIN CREAM [GLENMARK PHARMACEUTICALS INC., USA] 4 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP MUPIROCIN CREAM [GLENMARK PHARMACEUTICALS INC., USA] 4 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T MUPIROCIN CREAM [GLENMARK PHARMACEUTICALS INC., USA] 4 POLYOXYL 20 CETOSTEARYL ETHER INACTIVE INGREDIENT YRC528SWUY MUPIROCIN CREAM [GLENMARK PHARMACEUTICALS INC., USA] 4 WATER INACTIVE INGREDIENT 059QF0KO0R MUPIROCIN CREAM [GLENMARK PHARMACEUTICALS INC., USA] 4 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE MUPIROCIN CREAM [GLENMARK PHARMACEUTICALS INC., USA] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-564 MUPIROCIN CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 Current NDC, Legacy NDC, 2 package rows 20240104_acd6e23e-d83f-4ed8-9c50-467ed422a8c4.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68462-564-17 68462056417 15 g in 1 TUBE (68462-564-17) 15 g 2013-01-24 0000-00-00 No No Current 68462-564-35 68462056435 30 g in 1 TUBE (68462-564-35) 30 g 2013-01-24 0000-00-00 No No Current