NDC 60219-1362-01 - LOTEPREDNOL ETABONATE
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
- 60219-1362
- Requested NDC
- 60219-1362-01
- Package NDCs from labels
- 60219-1362-1, 60219-1362-2, 60219-1362-3, 60219-1362-01
- Manufacturer
- Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited
- Effective date
- 2025-05-21
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Loteprednol Etabonate Ophthalmic Suspension, 0.5% STERILE OPHTHALMIC SUSPENSION | Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited | 2025-05-21 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60219-1362-1 | LOTEPREDNOL ETABONATE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | 4 | |
| 60219-1362-1 | LOTEPREDNOL ETABONATE | 5 mL in 1 BOTTLE | SUSPENSION/ DROPS | 5 | 4 | |
| 60219-1362-2 | LOTEPREDNOL ETABONATE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | 4 | |
| 60219-1362-2 | LOTEPREDNOL ETABONATE | 10 mL in 1 BOTTLE | SUSPENSION/ DROPS | 10 | 4 | |
| 60219-1362-3 | LOTEPREDNOL ETABONATE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | 4 | |
| 60219-1362-3 | LOTEPREDNOL ETABONATE | 15 mL in 1 BOTTLE | SUSPENSION/ DROPS | 15 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60219-1362 | LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC] | 4 | Current NDC, 6 package rows | 20250523_e8b50444-fd49-427e-9c1b-f75cb1b62bb6.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60219-1362-1 | ML - Milliliter | 60219-1362 | 52ef0097-98f1-4f6b-b09f-7f696ca37811 | 1 | 2025-09-12 |
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 |
|---|---|---|---|---|---|---|
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a28101f-ea8e-6071-e063-6294a90aad91 | 2026-08-31 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a3e62ce-52dc-121b-e063-6294a90a898f | 2026-08-31 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a49db18-c270-6f46-e063-6294a90afb5d | 2026-08-31 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a4ac18e-8ba5-bef6-e063-6394a90a8811 | 2026-08-31 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a4d11fa-3f65-b41f-e063-6394a90a30ae | 2026-08-31 | Warnings | F5UM2KM3W7 |
| Orajel 4X Medicated Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1b4133-0eac-2f8f-e063-6394a90af8f6 | 2026-08-28 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59ed87d5-dab1-abab-e063-6394a90a024d | 2026-08-26 | Warnings | F5UM2KM3W7 |
| KUGIG ALOE FOAMING INTIMATE WASH | INTIMATE CLEANSING FOAM | Hong Kong KangXing Centennial Management Limited | 59f4d398-1186-a168-e063-6294a90ab44b | 2026-08-26 | Warnings | 059QF0KO0R |
| Mercurochrome | BENZALKONIUM CHLORIDE | Vitamex USA, Corp | 21652b11-715d-0c54-e063-6294a90a8855 | 2026-08-26 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59fa27b4-dfd4-720b-e063-6394a90af659 | 2026-08-26 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59fb22d6-f6a4-42cd-e063-6394a90a859a | 2026-08-26 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59fbb054-461e-aa6e-e063-6394a90a470c | 2026-08-26 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59e742a6-61f9-59f7-e063-6394a90a8738 | 2026-08-25 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59e7dfb1-49b5-d2be-e063-6394a90a04d8 | 2026-08-25 | Warnings | F5UM2KM3W7 |
| Sterile Water | WATER | REMEDYREPACK INC. | 5dd5d148-6e23-41de-bff5-551b2aea9598 | 2026-08-24 | Warnings, Adverse reactions | 059QF0KO0R |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59d3c369-86aa-8ebd-e063-6394a90aa806 | 2026-08-24 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59d7fc3c-3a93-153d-e063-6394a90ac647 | 2026-08-24 | Warnings | F5UM2KM3W7 |
| Claravie | BENZALKONIUM CHLORIDE | Gentell LLC | 59887af3-9b22-9664-e063-6294a90a57c6 | 2026-08-21 | Warnings | F5UM2KM3W7 |
| Family Beauty Antibacterial Hand Wipes | BENZALKONIUM CHLORIDE | Zhejiang Bright Care Co., Ltd. | 6ff604f7-4011-4f0e-aa2d-a46e1a973d13 | 2026-08-21 | Warnings | F5UM2KM3W7 |
| Softsoap Antibacterial Clean and Protect Cool Splash | BENZALKONIUM CHLORIDE | COLGATE PALMOLIVE COMPANY | 7d48e018-0874-4bbf-a95e-dc21702406c1 | 2026-08-20 | Warnings | F5UM2KM3W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.