NDC 69238-1155-03 - Ezetimibe and Simvastatin
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
- 69238-1155
- Requested NDC
- 69238-1155-03
- Package NDCs from labels
- 69238-1155-3, 69238-1155-9, 69238-1155-03
- Manufacturer
- Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited
- Effective date
- 2025-01-30
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Ezetimibe and Simvastatin - Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited | Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited | 2025-01-30 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69238-1155-3 | Ezetimibe and Simvastatin | 30 in 1 BOTTLE | TABLET | 30 | 13 | |
| 69238-1155-9 | Ezetimibe and Simvastatin | 90 in 1 BOTTLE | TABLET | 90 | 13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69238-1155 | EZETIMIBE AND SIMVASTATIN TABLET [AMNEAL PHARMACEUTICALS NY LLC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20250427_5ea3ca31-cfee-4978-8b7a-755986f6b091.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69238-1155-3 | EA - Each | 69238-1155 | 0928c99f-78e2-408a-832e-2a962fccfed6 | 1 | 2018-01-12 |
| 69238-1155-9 | EA - Each | 69238-1155 | bbde07ed-e1ce-43c3-9954-013cd0eec897 | 1 | 2018-01-12 |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | e447cc46-adee-4126-8b85-f00f81a6e93c | 2026-07-08 | Warnings, Adverse reactions | AGG2FN16EV |
| Artificial Tears | ARTIFICIAL TEARS | AvPAK | f18bebf2-1936-658f-e053-2a95a90a5012 | 2026-07-07 | Warnings | 3NXW29V3WO |
| Simvastatin | SIMVASTATIN | Aphena Pharma Solutions - Tennessee, LLC | 55f92c72-e690-85dd-e063-6394a90adb39 | 2026-07-06 | Warnings, Adverse reactions | AGG2FN16EV |
| Ezetimibe | EZETIMIBE | A-S Medication Solutions | 090776cf-f211-49a3-a993-ff5d707311f2 | 2026-07-06 | Warnings, Adverse reactions | EOR26LQQ24 |
| Ezetimibe | EZETIMIBE | A-S Medication Solutions | a1cc2018-72a3-48bc-90de-c460f224cf5a | 2026-07-06 | Warnings, Adverse reactions | EOR26LQQ24 |
| SIMVASTATIN | SIMVASTATIN | St. Mary's Medical Park Pharmacy | f94d5907-737e-df67-e053-6394a90a82a6 | 2026-07-01 | Warnings, Adverse reactions | AGG2FN16EV |
| Simvastatin | SIMVASTATIN | Bryant Ranch Prepack | a3bfe314-1fe4-4d2a-aecb-4194f3bd8f22 | 2026-06-29 | Warnings, Adverse reactions | AGG2FN16EV |
| Nexlizet | BEMPEDOIC ACID AND EZETIMIBE | Esperion Therapeutics, Inc. | 3fa2108c-0300-47b8-9d34-f762af7c93c6 | 2026-06-25 | Warnings, Adverse reactions | EOR26LQQ24 |
| Rohto Sun and Sport | HYPROMELLOSE, POVIDONE | The Mentholatum Company | 8bcc8882-b886-4b55-9bc4-d4b92a41358f | 2026-06-19 | Warnings | 3NXW29V3WO |
| Rohto Dual Light Relief | HYPROMELLOSE, POVIDONE | The Mentholatum Company | 1b597f83-d7f1-cf93-e063-6394a90a99f7 | 2026-06-19 | Warnings | 3NXW29V3WO |
| ACD A | CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE | Terumo BCT, Ltd. | 395aec48-198a-4aed-8e38-7accfb3232f9 | 2026-06-15 | Warnings, Adverse reactions | 2968PHW8QP |
| GUNA-CELL | ACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINC | Guna spa | 90db80ed-c037-4e8f-a7f6-304a65f9fe22 | 2026-06-11 | Warnings | 2968PHW8QP |
| GUNA-FLAM | ACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT - | Guna spa | 7bda7eb0-8fd5-42d9-b336-39920bfc964d | 2026-06-10 | Warnings | 2968PHW8QP |
| Rohto All-In-One | HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE | The Mentholatum Company | 43e690e4-b381-46e3-838c-33aef5bdadde | 2026-06-03 | Warnings | 3NXW29V3WO |
| Rohto Digi-Eye | HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE | The Mentholatum Company | 5d6f37b9-b568-4cb6-92de-eb40779f3f8c | 2026-06-03 | Warnings | 3NXW29V3WO |
| SIMVASTATIN | SIMVASTATIN | St. Mary's Medical Park Pharmacy | faa81817-3ffa-b83c-e053-6294a90a3f85 | 2026-06-02 | Warnings, Adverse reactions | AGG2FN16EV |
| SIMVASTATIN | SIMVASTATIN | St. Mary's Medical Park Pharmacy | f94e5e28-f0b1-700a-e053-6394a90adb7b | 2026-06-01 | Warnings, Adverse reactions | AGG2FN16EV |
| SIMVASTATIN | SIMVASTATIN | Coupler LLC | 5257271e-5c07-4996-e063-6394a90a4424 | 2026-05-21 | Warnings, Adverse reactions | AGG2FN16EV |
| SIMVASTATIN | SIMVASTATIN | Coupler LLC | 52573b98-6e51-9753-e063-6294a90ac8c4 | 2026-05-21 | Warnings, Adverse reactions | AGG2FN16EV |
| ACD A | CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE | Terumo BCT, Ltd | 8e255bc7-a120-460a-a32d-43931f8115de | 2026-05-21 | Warnings, Adverse reactions | 2968PHW8QP |