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 |
|---|---|---|---|---|---|---|
| ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | ZO Skin Health Inc. | 4f81e482-8111-451c-e063-6294a90ad148 | 2026-04-15 | Warnings | 15FIX9V2JP |
| Fluoxetine | FLUOXETINE | REMEDYREPACK INC. | a1b40d46-5233-49d7-9833-762cb6999012 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 310384 I9W7N6B1KJ |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | UNDRBUDR, LLC | 4f8353b3-4ac1-9703-e063-6294a90abdad | 2026-04-15 | Warnings | 15FIX9V2JP |
| Mineral Sunscreen Stick Non-Tinted | TITANIUM DIOXIDE, ZINC OXIDE | UNDRBUDR, LLC | 4f83dd76-a8d8-916e-e063-6294a90ab6ed | 2026-04-15 | Warnings | 15FIX9V2JP |
| Mineral Sunscreen Stick - Tinted | TITANIUM DIOXIDE, ZINC OXIDE | UNDRBUDR, LLC | 4f84619f-3415-7443-e063-6394a90a162a | 2026-04-15 | Warnings | 15FIX9V2JP |
| Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory | TITANIUM DIOXIDE AND ZINC OXIDE | PML NYC, LLC | 1be639a8-179a-7015-e063-6394a90ab64b | 2026-04-15 | Warnings | 15FIX9V2JP |
| DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30 | DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30 | PML NYC, LLC | ea90bb4d-6f4a-45c9-e053-2a95a90a53a7 | 2026-04-15 | Warnings | 15FIX9V2JP |
| YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTER | YOUR NAME MINERAL SHEER TINT | PML NYC, LLC | 0e24a63e-d76f-6581-e063-6394a90a6181 | 2026-04-15 | Warnings | 15FIX9V2JP |
| Sei Bella Tinted BB Moisturizing Cream | 115 N | PML NYC, LLC | 316e8ac6-f8fa-7add-e063-6294a90a4f24 | 2026-04-15 | Warnings | 15FIX9V2JP |
| ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light) | TITANIUM DIOXIDE, ZINC OXIDE | ZO Skin Health Inc. | 4f8756bf-5b0d-5269-e063-6294a90ae6dc | 2026-04-15 | Warnings | 15FIX9V2JP |
| ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light Medium) | TITANIUM DIOXIDE, ZINC OXIDE | ZO Skin Health Inc. | 4f87e24f-e4ff-03a7-e063-6294a90a23b1 | 2026-04-15 | Warnings | 15FIX9V2JP |
| YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 Cameo Glow | YOUR NAME MINERAL SHEER TINT | PML NYC, LLC | 316cd602-8af5-fbb6-e063-6294a90a287b | 2026-04-15 | Warnings | 15FIX9V2JP |
| Fluoxetine | FLUOXETINE | NCS HealthCare of KY, LLC dba Vangard Labs | faf4bc0c-bf65-4a65-8f08-3d800185d6a8 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 313989 I9W7N6B1KJ |
| BANANA BOAT | TITANIUM DIOXIDE,ZINC OXIDE | Edgewell Personal Care Brands LLC | 4f5896a6-0639-5589-e063-6294a90a45a9 | 2026-04-13 | Warnings | 15FIX9V2JP |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | d121146e-7439-4169-a421-dab7b882b8aa | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | ANDA204597 70518-3554-2 70518-3554-1 70518-3554-0 70518-3554 70518355401 313989 4f58fac7-b244-631c-e063-6294a90a0434 d121146e-7439-4169-a421-dab7b882b8aa I9W7N6B1KJ |
| Artificial Tears Lubricant Eye Drops | GLYCERIN, PROPYLENE GLYCOL | CVS Pharmacy | 28297fee-8185-4869-8f39-5bfbf8bf8bfd | 2026-04-13 | Warnings | 6DC9Q167V3 |
| Dentastat | ALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PALLADIUM METALLICUM, PHOSPHORUS, SILICEA, TITANIUM METALLICUM, ZINCUM METALLICUM, PLATINUM METALLICUM, PYROGENIUM | Energique, Inc. | 7f6d360b-9fee-4374-a47c-847806d54fa0 | 2026-04-13 | Warnings | ETJ7Z6XBU4 |
| Retaine Ultra PF | POLYETHYLENE GLYCOL | OCuSOFT LLC | a5aaaf06-772d-44d3-8601-f978ddc48ad7 | 2026-04-13 | Warnings | 6DC9Q167V3 |
| TRUST MD SPF30 STEM CELL FACE | OCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDE | Guangzhou Yapheon Health Industry Co., Ltd. | 4f2ca12c-bc6f-61b8-e063-6294a90a0d7e | 2026-04-11 | Warnings | 15FIX9V2JP |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 8b8fe00e-7a2f-486b-9b72-465a494d8939 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | ANDA204597 310384 I9W7N6B1KJ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.