Mupirocin
- Product NDC
- 68462-180
- Requested package NDC
- 68462-180-22
- 11-digit product format
- 684620180
- Labeler code
- 68462
- Product ID
- 68462-180_1560b587-27d8-49cd-9b43-21cc6c30afc1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mupirocin
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA090480
- Marketing category
- ANDA
- Marketing start
- 2011-06-08
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090480-001 | MUPIROCIN | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090480-001 | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A090480-001 | MUPIROCIN | 2% | OINTMENT / TOPICAL | AB | 2011-06-08 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090480-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090480-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090480-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090480-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090480-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090480-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090480-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090480-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090480-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090480-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090480-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090480-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090480-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090480-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090480-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090480-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090480-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090480-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090480-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090480-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090480-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090480-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090480-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090480-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090480-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090480-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090480-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090480-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090480-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090480-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090480-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090480-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090480-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090480-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090480-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090480-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090480-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090480-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090480-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090480-001 | AB | 1 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mupirocin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MUPIROCIN | 20 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| D0GX863OA5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 106346 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ff7428fb-9ce9-4743-b58c-01a05424a57a | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68462-180-22 | Mupirocin | 22 g in 1 TUBE | OINTMENT | 22 | 15 | |
| 68462-180-22 | NuSurgePak Surgical Prep/CarePak | 22 g in 1 TUBE | OINTMENT | 22 g | 20 mg in 1g | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68462-180-22 | GM - Gram | 68462-180 | e0529691-3667-4a86-a08f-60f0194e9750 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68462-180 | MUPIROCIN OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] | 14 | Current NDC, Legacy NDC, 1 package rows | 20231125_ff7428fb-9ce9-4743-b58c-01a05424a57a.zip |
| 68462-180 | NUSURGEPAK SURGICAL PREP/CAREPAK (CHLORHEXIDINE GLUCONATE, MUPIROCIN, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS INC] | 2 | Current NDC, Legacy NDC | 20200623_a83a55e8-58df-ac57-e053-2a95a90a9425.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mupirocin | MUPIROCIN | Preferred Pharmaceuticals Inc. | 06a4ee22-d8f8-4a8a-8666-82b14f2d8476 | 2026-07-28 | Warnings, Adverse reactions | 090480 ANDA090480 |
| Mupirocin | MUPIROCIN | Glenmark Pharmaceuticals Inc., USA | ff7428fb-9ce9-4743-b58c-01a05424a57a | 2025-10-28 | Warnings, Adverse reactions | 090480 ANDA090480 68462-180-22 68462-180 68462018022 |
| Mupirocin | MUPIROCIN | NuCare Pharmaceuticals,Inc. | 5abf8c5c-e9c9-3b59-e053-2a91aa0ae394 | 2025-01-02 | Warnings, Adverse reactions | 090480 ANDA090480 |
| Mupirocin | MUPIROCIN | Proficient Rx LP | 2777e4f2-2b8d-41f5-a96a-02dec8c7c3e0 | 2023-11-01 | Warnings, Adverse reactions | 090480 ANDA090480 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68462-180-22 | 68462018022 | 22 g in 1 TUBE (68462-180-22) | 22 g | 2011-06-08 | 0000-00-00 | No | No | Current |