Livalo
- Product NDC
- 66869-204
- 11-digit product format
- 668690204
- Labeler code
- 66869
- Product ID
- 66869-204_f558f406-3b8e-4a4b-a817-2fb2e624c79c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pitavastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kowa Pharmaceuticals America, Inc.
- Application
- NDA022363
- Marketing category
- NDA
- Marketing start
- 2019-05-16
- Substance
- PITAVASTATIN CALCIUM
- Active strength
- 2.09 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Livalo
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PITAVASTATIN CALCIUM | 2.09 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IYD54XEG3W |
| Rxcui | 861643, 861646, 861648, 861650, 861652, 861654 |
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 |
|---|
| 66869-204-07 | Livalo | 7 in 1 CARTON | TABLET, FILM COATED | 7 | | 11 |
| 66869-204-90 | Livalo | 90 in 1 BOTTLE, DISPENSING | TABLET, FILM COATED | 90 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| pitavastatin calcium | ACTIVE INGREDIENT | IYD54XEG3W | LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | 3 | |
| pitavastatin | ACTIVE MOIETY | M5681Q5F9P | LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | 3 | |
| hydroxypropyl cellulose, low substituted | INACTIVE INGREDIENT | 2165RE0K14 | LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | 3 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | 3 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | 3 | |
| magnesium aluminometasilicate type i-b | INACTIVE INGREDIENT | 8XK1039013 | LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | 3 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | 3 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | 3 | |
| triethyl citrate | INACTIVE INGREDIENT | 8Z96QXD6UM | LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66869-204 | LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240906_44dcbf97-99ec-427c-ba50-207e0069d6d2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66869-204-07 | 66869020407 | 7 TABLET, FILM COATED in 1 CARTON (66869-204-07) | 2019-05-16 | 0000-00-00 | No | No | Current |
| 66869-204-90 | 66869020490 | 90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-204-90) | 2019-05-16 | 0000-00-00 | No | No | Current |