simvastatin
- Product NDC
- 33261-542
- 11-digit product format
- 332610542
- Labeler code
- 33261
- Product ID
- 33261-542_733c33c5-9968-4f49-9f73-2aab91932134
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA078155
- Marketing category
- ANDA
- Marketing start
- 2008-02-26
- Marketing end
- 0000-00-00
- Substance
- SIMVASTATIN
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33261-542-30 | simvastatin | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 33261-542-60 | simvastatin | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
| 33261-542-90 | simvastatin | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SIMVASTATIN | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SIMVASTATIN | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33261-542 | SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 3 package rows | 20140213_0f878e82-7ce1-450b-abb0-2090c22b389b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 33261-542-30 | 33261054230 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 33261-542-60 | 33261054260 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 33261-542-90 | 33261054290 | 90 in 1 BOTTLE, PLASTIC | Historical |