Corlanor
- Product NDC
- 55513-813
- 11-digit product format
- 555130813
- Labeler code
- 55513
- Product ID
- 55513-813_8ab000cd-0258-489a-b1bb-4cc1ca359d6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ivabradine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amgen Inc
- Application
- NDA209964
- Marketing category
- NDA
- Marketing start
- 2019-04-19
- Substance
- IVABRADINE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- Pharmacologic classes
- Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Corlanor
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IVABRADINE HYDROCHLORIDE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TP19837BZK |
| Rxcui | 1649485, 1649491, 1649493, 1649495, 2168592, 2168596 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55513-813-01 | Corlanor | 5 mL in 1 AMPULE | SOLUTION | 5 | | 33 |
| 55513-813-28 | Corlanor | 28 in 1 CARTON | SOLUTION | 28 | | 33 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IVABRADINE HYDROCHLORIDE | ACTIVE INGREDIENT | TP19837BZK | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
| IVABRADINE | ACTIVE MOIETY | 3H48L0LPZQ | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55513-813 | CORLANOR (IVABRADINE) TABLET, FILM COATED CORLANOR (IVABRADINE) SOLUTION [AMGEN INC] | 31 | Current NDC, Legacy NDC, 2 package rows | 20230615_92018a65-38f6-45f7-91d4-a34921b81d0d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55513-813-01 | 55513081301 | 5 mL in 1 AMPULE | 5 ml | | | | | Historical |
| 55513-813-28 | 55513081328 | 28 AMPULE in 1 CARTON (55513-813-28) / 5 mL in 1 AMPULE (55513-813-01) | 28 ampule | 2019-04-19 | 0000-00-00 | No | No | Current |