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 | Proficient Rx LP | 9528a356-4101-4be2-a7e2-b0659e169e1a | 2021-01-01 | Warnings, Adverse reactions | 804826J2HU |
| Post - Vaccination | INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM | Newton Laboratories, Inc. | 997474d5-4dc4-6104-e053-2995a90a03f1 | 2020-12-07 | Warnings | ETJ7Z6XBU4 |
| Oral Care-Gingivitis | ACONITUM NAP., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CALENDULA, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM, HEPAR SULPH. CALC., KREOSOTUM, MERC. VIV., MYRRHA, NUX VOM., PHOSPHORUS, PHYTOLACCA, PLANTAGO, RHUS TOXICODENDRON, SILICEA, STAPHYSAG., ECHINACEA | Newton Laboratories, Inc. | 9971a7f4-c02c-02ba-e053-2a95a90a2b73 | 2020-12-04 | Warnings | ETJ7Z6XBU4 |
| Female Femroids | HYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, ARSENICUM ALBUM, CALCAREA IODATA, CARBO ANIMALIS, CONIUM MACULATUM, GRAPHITES, HYDRASTIS CANADENSIS, IODIUM, KREOSOTUM, LACHESIS MUTUS, PHOSPHORUS, SABINA, SECALE CORNUTUM, SEPIA, SILICEA, THLASPI BURSA-PASTORIS, THUJA OCCIDENTALIS, THYROIDINUM, TRILLIUM PENDULUM, USTILAGO MAIDIS. | Newton Laboratories, Inc. | 9a01acb9-1b2b-3a33-e053-2995a90adc92 | 2020-12-03 | Warnings | ETJ7Z6XBU4 |
| Fungal | CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC. | Newton Laboratories, Inc. | 99487f4a-76f6-407b-e053-2a95a90acfd4 | 2020-12-03 | Warnings | ETJ7Z6XBU4 |
| G-Inflamm | CHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, COLOCYNTHIS, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IPECACUANHA, KALI BICHROMICUM, KALI CARBONICUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, MAGNESIA PHOSPHORICA, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, ZINGIBER OFFICINALE. | Newton Laboratories, Inc. | 9a153c45-0142-5abb-e053-2995a90a71f5 | 2020-12-03 | Warnings | 0E53J927NA |
| Thyroid-Adrenal | ADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEA | Newton Laboratories, Inc. | b59731a2-c775-7e8a-e053-2a95a90a9062 | 2020-12-03 | Warnings | ETJ7Z6XBU4 |
| Acne - Cystic Acne | ECHINACEA, JUGLANS REGIA, LAPPA MAJOR, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, AURUM METALLICUM, BERBERIS AQUIFOLIUM, BOVISTA, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, LEDUM PALUSTRE, LYCOPDIUM CLAVATUM, NUX VOMICA, SULPHUR IODATUM, ZINCUM METALLICUM, SILICEA | Newton Laboratories, Inc | 92afe017-74c7-16c6-e053-2995a90a5c7d | 2020-12-02 | Warnings | ETJ7Z6XBU4 |
| Breast Care - Fibrocystic | BUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUM | Newton Laboratories, Inc. | 98d01128-9887-12ce-e053-2a95a90a7329 | 2020-12-02 | Warnings | ETJ7Z6XBU4 |
| Connec-T | ECHINACEA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, CALCAREA FLUORICA, CAPSICUM ANNUUM, CARDUUS MARIANUS, CINCHONA OFFICINALIS, IODIUM, KALI CARBONICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MERCURIUS VIVUS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, SECALE CORNUTUM, THYMUS SERPYLLUM, THUJA OCCIDENTALIS, THYROIDINUM, VERBASCUM THAPSUS. | Newton Laboratories, Inc. | 9a630923-1497-1fc8-e053-2995a90ad001 | 2020-12-02 | Warnings | 0E53J927NA |
| Thyroid-Adrenal | ADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEA | Newton Laboratories, Inc. | b56f2ffc-4637-1f23-e053-2a95a90aa3af | 2020-12-01 | Warnings | ETJ7Z6XBU4 |
| Hair-Scalp | APIS MEL., ARSENICUM ALB., CALC. CARB., DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, HYDROFLUORICUM ACIDUM, KALI CARB., LYCOPODIUM, MEZEREUM, OLEANDER, PETROLEUM, PHOSPHORICUM AC., PHOSPHORUS, RHUS TOXICODENDRON, SELENIUM, SEPIA, SILICEA, SULPHUR, THUJA OCC. | Newton Laboratories, Inc. | 9ab3b944-443c-74a1-e053-2a95a90aa0e5 | 2020-11-30 | Warnings | ETJ7Z6XBU4 |
| Sleep HP | ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS | Grato Holdings, Inc. | 90e8553a-cfa9-4bb1-a398-3242a4e7456b | 2020-11-30 | Warnings | 0E53J927NA |
| Acne | ANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUM | Newton Laboratories, Inc. | 798c853c-16ab-8502-e053-2a91aa0a6532 | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Acne | ANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUM | Newton Laboratories, Inc. | 798d5f34-819a-9895-e053-2991aa0a1d62 | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Bowel - Digestive Care | BISMUTHUM METALLICUM, ANTIMON.CRUD., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CHAMOMILLA, CINCHONA, IRIS VERSICOLOR, KALI BIC., LACHESIS, LYCOPODIUM, MAG. CARB., NUX VOM., PHOSPHORUS, PODOPH. PELT., PULSATILLA, RAPHANUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM, ZINGIBER, ECHINACEA, JUGLANS REGIA. | Newton Laboratories, Inc. | 907fafa5-2f75-f11d-e053-2a95a90a1fb8 | 2020-11-24 | Warnings | 0E53J927NA |
| Breast Care | BUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUM | Newton Laboratories, Inc. | 79edde91-f909-f7b3-e053-2991aa0a9d1c | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Constipation | ABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUM | Newton Laboratories, Inc. | 90807700-3099-850c-e053-2995a90ada55 | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Constipation | ABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUM | Newton Laboratories, Inc. | 90804a94-1e67-3ab3-e053-2a95a90aafbe | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Post - Vaccination | INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM | Newton Laboratories, Inc. | 9042b7ad-15ed-0e81-e053-2a95a90afe28 | 2020-11-23 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.