Sunlenca
- Product NDC
- 61958-3002
- 11-digit product format
- 619583002
- Labeler code
- 61958
- Product ID
- 61958-3002_12f3f90c-8b72-4e1f-875e-6fcaf4b15959
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LENACAPAVIR SODIUM
- Dosage form
- KIT
- Labeler
- Gilead Sciences, Inc.
- Application
- NDA215973
- Marketing category
- NDA
- Marketing start
- 2022-12-22
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sunlenca
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | BDT58WJ9WE |
| Rxcui | 2625890, 2625896, 2625897, 2625898, 2625899, 2625900, 2625904, 2625909, 2625911, 2625912 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a124dbe4-d4b1-4641-ba1c-c35ad0d241f9 | Product name | 1 | 20230919 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61958-3002-1 | Sunlenca | 1 in 1 CARTON | KIT | 1 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61958-3002-1 | ML - Milliliter | 61958-3002 | 8fe90940-34a0-4a39-8d90-49d34f5d4c6d | 1 | 2023-01-09 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61958-3002 | SUNLENCA (LENACAPAVIR SODIUM) TABLET, FILM COATED SUNLENCA (LENACAPAVIR SODIUM) KIT [GILEAD SCIENCES, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250406_e5652804-29c4-40d7-aeb2-0142ed2a7b5b.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2625912 | {2 (1.5 ML lenacapavir 309 MG/ML Injection [Sunlenca]) } Pack [Sunlenca 927 MG Kit] | BPCK | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625898 | {4 (lenacapavir 300 MG Oral Tablet [Sunlenca]) } Pack [Sunlenca 4-Tablet Pack] | BPCK | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625900 | {5 (lenacapavir 300 MG Oral Tablet [Sunlenca]) } Pack [Sunlenca 5-Tablet Pack] | BPCK | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625911 | {2 (1.5 ML lenacapavir 309 MG/ML Injection) } Pack | GPCK | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625897 | {4 (lenacapavir 300 MG Oral Tablet) } Pack | GPCK | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625899 | {5 (lenacapavir 300 MG Oral Tablet) } Pack | GPCK | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625897 | lenacapavir 300 MG 4-Tablet Pack | PSN | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625899 | lenacapavir 300 MG 5-Tablet Pack | PSN | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625890 | lenacapavir 300 MG Oral Tablet | PSN | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625904 | lenacapavir 463.5 MG in 1.5 ML Injection | PSN | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625911 | lenacapavir 927 MG 2-Vial Kit | PSN | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625896 | Sunlenca 300 MG Oral Tablet | PSN | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625898 | Sunlenca 4-Tablet Pack | PSN | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625909 | Sunlenca 463.5 MG in 1.5 ML Injection | PSN | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625900 | Sunlenca 5-Tablet Pack | PSN | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625912 | Sunlenca 927 MG 2-Vial Kit | PSN | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625909 | 1.5 ML lenacapavir 309 MG/ML Injection [Sunlenca] | SBD | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625896 | lenacapavir 300 MG Oral Tablet [Sunlenca] | SBD | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625904 | 1.5 ML lenacapavir 309 MG/ML Injection | SCD | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625890 | lenacapavir 300 MG Oral Tablet | SCD | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625909 | 1.5 ML Sunlenca 309 MG/ML Injection | SY | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625890 | lenacapavir 300 MG (as lenacapavir sodium 306.8 MG) Oral Tablet | SY | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625897 | lenacapavir 300 MG 4-Tablet Pack | SY | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625899 | lenacapavir 300 MG 5-Tablet Pack | SY | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625904 | lenacapavir 463.5 MG per 1.5 ML Injection | SY | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625911 | lenacapavir 927 MG 2-Vial Kit | SY | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625896 | Sunlenca 300 MG Oral Tablet | SY | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625898 | Sunlenca 4-Tablet Pack | SY | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625909 | Sunlenca 463.5 MG per 1.5 ML Injection | SY | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625900 | Sunlenca 5-Tablet Pack | SY | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
| 2625912 | Sunlenca 927 MG 2-Vial Kit | SY | e5652804-29c4-40d7-aeb2-0142ed2a7b5b | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61958-3002-1 | 61958300201 | 1 KIT in 1 CARTON (61958-3002-1) * 1.5 mL in 1 VIAL (61958-3004-1) | 1 kit | 2022-12-22 | 0000-00-00 | No | No | Current |