NDC 57237-001-01 - Lansoprazole, Amoxicillin, Clarithromycin
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
- 57237-001
- Requested NDC
- 57237-001-01
- Package NDCs from labels
- 57237-001-01, 57237-001-14
- Manufacturer
- Rising Pharma Holdings, Inc. | Aurobindo Pharma Limited
- Effective date
- 2025-02-19
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Lansoprazole - Rising Pharma Holdings, Inc. | Aurobindo Pharma Limited | Rising Pharma Holdings, Inc. | Aurobindo Pharma Limited | 2025-02-19 | Human Prescription Drug Label |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57237-001-14 | 2022-04-20 | C162847 | 48780-1 | 9d75b9d0-f016-f424-e053-dadaa90a57ce | Lansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg Rx only |
| 57237-001-14 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f016-f424-e053-dadaa90a57ce | Lansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-001-01 | Lansoprazole, Amoxicillin, Clarithromycin | 1 in 1 BLISTER PACK | KIT | 1 | 13 | |
| 57237-001-14 | Lansoprazole, Amoxicillin, Clarithromycin | 14 in 1 CARTON | KIT | 14 | 13 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-001-01 | EA - Each | 57237-001 | 01b6981f-89ce-49c1-917d-2a9c12aae7c1 | 1 | 2016-12-07 |
| 57237-001-14 | EA - Each | 57237-001 | fef45051-3218-445a-b742-a73b7e58fa0d | 1 | 2016-11-08 |
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 |
|---|---|---|---|---|---|---|
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 116f655e-e32f-5030-e063-6394a90a64e5 | 2024-02-15 | Warnings, Adverse reactions | 308191 804826J2HU |
| Sheet SPF 30 Mineral | TITANIUM DIOXIDE, ZINC OXIDE | Vivier Pharma Inc. | bbb5b87c-d641-3ba2-e053-2a95a90a0f70 | 2024-02-14 | Warnings | 15FIX9V2JP |
| sheer tint SPF 45 | BROAD SPECTRUM | CP Skin Health Group, Inc. | b7c5cedd-ff68-74de-e053-2a95a90a3796 | 2024-02-14 | Warnings | 15FIX9V2JP |
| Lansoprazole | LANSOPRAZOLE | NuCare Pharmaceuticals,Inc. | 11344047-7ed4-61e7-e063-6394a90a332d | 2024-02-12 | Warnings, Adverse reactions | 311277 0K5C5T2QPG |
| REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O | OCTINOXATE, TITANIUM DIOXIDE | CLINIQUE LABORATORIES LLC | 10f7ec01-541b-a15a-e063-6294a90aa9df | 2024-02-09 | Warnings | 15FIX9V2JP |
| Perfect Sleep | ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH) | Deseret Biologicals, Inc. | 6d934960-63c6-4536-bde3-38c26f8083dc | 2024-02-06 | Warnings | ETJ7Z6XBU4 |
| Lansoprazole | LANSOPRAZOLE | Bryant Ranch Prepack | e0299cf2-8a8e-499b-a81e-16e844ea3aff | 2024-02-06 | Warnings, Adverse reactions | 311277 0K5C5T2QPG |
| COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden Hour | TITANIUM DIOXIDE | COOLA, LLC | edfda0f5-0f72-5cc7-e053-2a95a90ae38d | 2024-02-02 | Warnings | 15FIX9V2JP |
| COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush | ZINC OXIDE | COOLA, LLC | edc6754e-dabb-5bff-e053-2a95a90a7390 | 2024-02-02 | Warnings | 15FIX9V2JP |
| COOLA Mineral Liplux Lip Balm SPF 30 Skinny Dip | ZINC OXIDE | COOLA, LLC | ee01f936-81a9-a54d-e053-2a95a90a5227 | 2024-02-02 | Warnings | 15FIX9V2JP |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | 0d40bc70-8f47-48c2-a7c6-ba7db9cace74 | 2024-02-01 | Warnings, Adverse reactions | 804826J2HU |
| toty Solaria Mineral | TITANIUM DIOXIDE, ZINC OXIDE | Chipican LLC | e9d590d8-e71a-0715-e053-2a95a90a5acf | 2024-02-01 | Warnings | 15FIX9V2JP |
| Clarithromycin | CLARITHROMYCIN | Proficient Rx LP | 28f60574-4ecd-441c-aebe-5b1d18033ef6 | 2024-02-01 | Warnings, Adverse reactions | 197517 H1250JIK0A |
| Amoxicillin | AMOXICILLIN | Hikma Pharmaceuticals USA Inc. | d46f1091-33dc-4f8f-9c34-75dcfedb4b4c | 2024-02-01 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | Hikma Pharmaceuticals USA Inc. | 077f4a65-3cfb-4cb1-99f2-e27ffc5939c0 | 2024-02-01 | Warnings, Adverse reactions | 804826J2HU |
| Silicea | SILICON DIOXIDE | SEVENE USA | 0805d866-ce1a-4f54-8a44-83d4902e8c0d | 2024-01-30 | Warnings | ETJ7Z6XBU4 |
| ATOMY DERMA CALMING SUN | TITANIUM DIOXIDE | ATOMY CO., LTD. | fd5fc3ba-6e7c-4e48-8e65-47c03141df45 | 2024-01-30 | Warnings | 15FIX9V2JP |
| Topcare Swimmers Ear Drops | ISOPROPYL ALCOHOL | Topco Associates LLC | 0fddeb43-fee0-d43c-e063-6394a90a738a | 2024-01-26 | Warnings | ND2M416302 |
| Alcohol | ISOPROPYL ALCOHOL | NorMed | 441b915a-287f-4734-b4d9-730b3d95e04c | 2024-01-24 | Warnings | ND2M416302 |
| Amoxicillin | AMOXICILLIN | Aurobindo Pharma Limited | 7e3a4517-1934-4e03-b96b-4ad65ab076c5 | 2024-01-23 | Warnings, Adverse reactions | 308191 804826J2HU |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.