NDC 70518-3554-01 - Fluoxetine
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
- 70518-3554
- Requested NDC
- 70518-3554-01
- Package NDCs from labels
- 70518-3554-0, 70518-3554-1, 70518-3554-2, 70518-3554-01
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2026-10-13
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Fluoxetine - REMEDYREPACK INC. | REMEDYREPACK INC. | 2026-10-13 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-3554-0 | Fluoxetine | 30 in 1 BLISTER PACK | CAPSULE | 30 | 8 | |
| 70518-3554-1 | Fluoxetine | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | 8 | |
| 70518-3554-2 | Fluoxetine | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-3554 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REMEDYREPACK INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20250507_d121146e-7439-4169-a421-dab7b882b8aa.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 |
|---|---|---|---|---|---|---|
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | a5d49dee-a7de-44d8-80b5-1aeb89e76938 | 2023-08-05 | Boxed warning, Warnings, Adverse reactions | ANDA204597 310385 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | Teva Pharmaceuticals USA, Inc. | 06d71a33-5578-4012-b11d-764f45bc1e6a | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | 310384 310385 I9W7N6B1KJ |
| Fluoxetine Hydrochloride | FLUOXETINE HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | dd659085-c32d-4d35-9d4b-bafa2a93f1fb | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | Alembic Pharmaceuticals Inc. | e9ee6e93-4a57-4fd1-a417-3944484dd32c | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | Dr.Reddy's Laboratories Inc. | 390c61e6-14dd-4391-45b8-0fb5f4652723 | 2023-07-31 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| MEB Puri-Mega | MEB PURI-MEGA | Kadesh Incoporation Co,Ltd | 018125f2-ad4b-b38a-e063-6294a90a7f6e | 2023-07-27 | Warnings | ETJ7Z6XBU4 |
| VACC HC | HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM (2021-2022), ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUM | Deseret Biologicals, Inc. | c100d87b-4d67-42ef-b7e2-fd3642a104b8 | 2023-07-18 | Warnings | ETJ7Z6XBU4 |
| Household Antigens | ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR | BioActive Nutritional | 3382df85-3ec5-4371-830e-4ed345b8f51b | 2023-07-14 | Warnings | 6DC9Q167V3 368GB5141J |
| Ammonium Causticum | AMMONIUM CAUSTICUM | Hahnemann Laboratories, INC. | 00653070-bf09-78d9-e063-6394a90a0bcf | 2023-07-13 | 5138Q19F1X | |
| Silicea | SILICEA | Ratis, LLC | 8c2b59e1-9936-486c-9a91-153e46f377e6 | 2023-07-13 | Warnings | ETJ7Z6XBU4 |
| Pneumotox | TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM, | BioActive Nutritional, Inc. | f8846fb1-92e5-4f8e-b3b3-bc620df90a62 | 2023-07-12 | Warnings | 6DC9Q167V3 ETJ7Z6XBU4 368GB5141J |
| Silicea | SILICON DIOXIDE | Boiron | ce6a0710-7c28-11e6-86bf-424c58303031 | 2023-07-11 | ETJ7Z6XBU4 | |
| Kidney Drainage | SOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUM | Deseret Biologicals, Inc. | 4f82e261-6101-48ab-b161-ded5aa41cd85 | 2023-06-27 | Warnings | ETJ7Z6XBU4 |
| Fluoxetine | FLUOXETINE | NorthStar Rx LLC | 70b4bd1b-d355-189e-a414-9fff182fd1cd | 2023-06-20 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| Calciforce | ARNICA MONTANA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), BORON CITRATE, SYMPHYTUM OFFICINALE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, LYCOPODIUM CLAVATUM, SILICEA, CALCAREA CARBONICA | BioActive Nutritional, Inc. | 1609ce3e-82c2-4597-86e6-847c944ddbe6 | 2023-06-07 | Warnings | ETJ7Z6XBU4 |
| Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium Shade | SPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADE | Autumn Harp | fd6807e1-c8c0-b361-e053-6294a90aea0c | 2023-06-05 | Warnings | 15FIX9V2JP |
| Silicea 6X | SILICEA 6X | True Botanica, LLC | fd296871-c491-7d30-e053-6294a90ab64d | 2023-06-02 | Warnings | ETJ7Z6XBU4 |
| Thinksport Mineral SPF 50 | ZINC OXIDE AND TITANIUM DIOXIDE | thinkOperations,LLC | 77b63c0b-353b-4f5f-95c7-6f7eeab81471 | 2023-05-30 | Warnings | 15FIX9V2JP |
| Think Kids Mineral SPF 50 | ZINC OXIDE AND TITANIUM DIOXIDE | thinkOperations,LLC | 25c59820-a08d-4abe-87ae-a787ac8b2ac2 | 2023-05-30 | Warnings | 15FIX9V2JP |
| Baby Nighttime Mucus Plus Cold Relief | CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA | Hyland's Inc. | 736b2487-e81d-d172-e053-2a91aa0ab0cf | 2023-04-17 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.