Home NDC 80425-0246 Mupirocin
Product NDC 80425-0246
11-digit product format 804250246
Labeler code 80425
Product ID 80425-0246_2a9ae6d7-049b-3bd5-e063-6394a90a651e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mupirocin
Dosage form OINTMENT
Route TOPICAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA065085
Marketing category ANDA
Marketing start 2023-01-11
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065085-001 MUPIROCIN MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065085-001 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 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065085-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2003-11-07 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Mupirocin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MUPIROCIN 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D0GX863OA5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106346 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 80425-0246-1 Mupirocin 1 in 1 CARTON OINTMENT 1 3 80425-0246-1 Mupirocin 22 g in 1 TUBE OINTMENT 22 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0246 MUPIROCIN OINTMENT [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 3 Current NDC, 2 package rows 20250102_f1a048d9-af57-a4a2-e053-2995a90a8663.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80425-0246-1 80425024601 1 TUBE in 1 CARTON (80425-0246-1) / 22 g in 1 TUBE 1 tube 2023-01-11 No No Current