ORKAMBI
- Product NDC
- 51167-122
- 11-digit product format
- 511670122
- Labeler code
- 51167
- Product ID
- 51167-122_e746b83a-cec1-40ab-8dba-7d8c1781e8b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lumacaftor and ivacaftor
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- Vertex Pharmaceuticals Incorporated
- Application
- NDA211358
- Marketing category
- NDA
- Marketing start
- 2022-09-02
- Substance
- IVACAFTOR; LUMACAFTOR
- Active strength
- 94; 75 mg/1; mg/1
- Pharmacologic classes
- Chloride Channel Activation Potentiators [MoA], Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inducers [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein 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
- ORKAMBI
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LUMACAFTOR | 94 mg/1 |
| IVACAFTOR | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1Y740ILL1Z, EGP8L81APK |
| Rxcui | 1655928, 1655934, 1812468, 1812470, 2053509, 2053512, 2053517, 2053519, 2611458, 2611460 |
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 |
|---|
| 51167-122-01 | ORKAMBI | 56 in 1 CARTON | GRANULE | 56 | | 24 |
| 51167-122-01 | ORKAMBI | 1 in 1 PACKET | GRANULE | 1 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ivacaftor | ACTIVE INGREDIENT | 1Y740ILL1Z | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| lumacaftor | ACTIVE INGREDIENT | EGP8L81APK | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| ivacaftor | ACTIVE MOIETY | 1Y740ILL1Z | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| lumacaftor | ACTIVE MOIETY | EGP8L81APK | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| CARMINIC ACID | INACTIVE INGREDIENT | CID8Z8N95N | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| FD&C Blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S) | INACTIVE INGREDIENT | 6N003M473W | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51167-122 | ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED ORKAMBI (LUMACAFTOR AND IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] | 21 | Current NDC, Legacy NDC, 2 package rows | 20241222_3fc1c40e-cfac-47a1-9e1a-61ead3570600.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 |
|---|
| 51167-122-01 | 51167012201 | 56 PACKET in 1 CARTON (51167-122-01) / 1 GRANULE in 1 PACKET | 56 packet | 2022-09-02 | 0000-00-00 | No | No | Current |