Home NDC 68462-560 Pirnuo
Product NDC 68462-560
11-digit product format 684620560
Labeler code 68462
Product ID 68462-560_dc6f3960-2e28-46f1-8619-de5aee5f97ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mupirocin
Dosage form CREAM
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA201587
Marketing category ANDA
Marketing start 2017-07-29
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 Pirnuo
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311877 Internal RxNorm lookup 2286614 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 68462-560-47 Pirnuo 1 in 1 CARTON CREAM 1 2 68462-560-47 Pirnuo 42.5 g in 1 BOTTLE CREAM 42.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-560 PIRNUO (MUPIROCIN) CREAM [GLENMARK PHARMACEUTICALS INC., USA] 2 Current NDC, Legacy NDC, 2 package rows 20240104_89c43f7b-1a88-45bf-a356-07518d4e7870.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 68462-560-47 68462056047 1 BOTTLE in 1 CARTON (68462-560-47) / 42.5 g in 1 BOTTLE 1 bottle 2019-07-29 0000-00-00 No No Current