NDC 85534-0097-01 - Levofloxacin
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 85534-0097
- Requested NDC
- 85534-0097-01
- Package NDCs from labels
- 85534-0097-0, 85534-0097-1, 85534-0097-2, 85534-0097-3, 85534-0097-4, 85534-0097-5, 85534-0097-6, 85534-0097-01
- Manufacturer
- HAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEM
- Effective date
- 2026-07-18
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Levofloxacin - HAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEM | HAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEM | 2026-07-18 | HUMAN PRESCRIPTION DRUG LABEL |
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 |
|---|---|---|---|---|---|---|
| No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Tawny | OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE | BCM Cosmetique SAS | 52c3378f-6b99-42fa-900e-8a693864c615 | 2021-06-29 | Warnings | 15FIX9V2JP |
| No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Vanilla | OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE | BCM Cosmetique SAS | d701c221-9f68-47ff-b766-2f4f1998649f | 2019-10-08 | Warnings | 15FIX9V2JP |
| No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Amber | OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE | BCM Cosmetique SAS | 7f5e6872-4d26-410e-8afe-16a016f9a399 | 2019-10-08 | Warnings | 15FIX9V2JP |
| No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm Ivory | OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE | BCM Cosmetique SAS | 1124ba7d-a328-409b-8c88-e74bb3e501f5 | 2019-10-08 | Warnings | 15FIX9V2JP |
| No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Honey | OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE | BCM Cosmetique SAS | 9c407dc7-fcde-4660-9a06-57bd8a6b867d | 2019-10-08 | Warnings | 15FIX9V2JP |
| No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Chestnut | OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE | BCM Cosmetique SAS | f07e8bb2-30ae-4337-ad60-84f55f2ff354 | 2019-10-08 | Warnings | 15FIX9V2JP |
| Levofloxacin | LEVOFLOXACIN | Proficient Rx LP | 30958610-3803-45e6-aa3c-d256decbe6e4 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | ANDA201043 199884 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | Hikma Pharmaceuticals USA Inc. | e680c759-16c5-4532-9c9c-f42c8c3df74a | 2019-03-28 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | Hikma Pharmaceuticals USA Inc. | f23c0df4-ae2a-446c-a9ba-dbbeb6ffaba5 | 2019-03-27 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | Baxter Healthcare Corporation | 70c87464-1806-480a-8ebd-3f02987ff436 | 2019-03-22 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| CLE CCC Golden Medium Deep | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | KW ABSC, INC. | b7a4847f-b84d-4f36-8787-104eccd838a0 | 2018-12-03 | Warnings | 15FIX9V2JP |
| CLE CCC Warm Medium Deep | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | KW ABSC, INC. | 229c20a3-6288-4ac3-9098-6d1622e906ab | 2018-11-29 | Warnings | 15FIX9V2JP |
| CLE CCC Warm Medium Light | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | KW ABSC, INC. | fc90fb8a-44b3-47cd-882e-94ed324ed389 | 2018-11-27 | Warnings | 15FIX9V2JP |
| CLE CCC Warm Medium | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | KW ABSC, INC. | b585f216-4234-47c5-9a6b-8b133ef48aae | 2018-11-27 | Warnings | 15FIX9V2JP |
| CLE CCC Warm Light | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | KW ABSC, INC. | 14891e26-b3b6-4545-99b1-da914b7f5629 | 2018-11-24 | Warnings | 15FIX9V2JP |
| Additox | TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | BioActive Nutritional, Inc. | 319ee2fe-58e3-495e-bf0d-df201f6fbb1c | 2018-07-18 | Warnings | 15FIX9V2JP |
| Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20 | YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20 | Mana Products | 657d5090-30a8-46d0-879d-469178aa234d | 2018-01-25 | Warnings | 15FIX9V2JP |
| Mineral Sunscreen Moisturizer Broad Spectrum SPF 20 | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs, Inc | 316c2132-ab81-47f6-8e80-71e9252a2663 | 2017-12-12 | Warnings | 15FIX9V2JP |
| Mineral Sunscreen Broad Spectrum SPF 45 | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs, Inc | 96d2d0f1-dbde-4b66-9b2c-9d07f7547066 | 2017-12-11 | Warnings | 15FIX9V2JP |
| Cover Recover SPF 30 Ivory | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs, Inc | fe207b88-8eb8-424d-89b4-8d5b188dd2c3 | 2017-12-05 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.