Adalimumab-aacf
- Product NDC
- 65219-620
- 11-digit product format
- 652190620
- Labeler code
- 65219
- Product ID
- 65219-620_ed59e023-eb91-482f-a1fe-19a31c0906c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- adalimumab
- Dosage form
- KIT
- Route
- SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- BLA761255
- Marketing category
- BLA
- Marketing start
- 2024-06-30
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Adalimumab-aacf
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 797544, 2640851, 2640859, 2640864, 2640869 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 58819a18-327d-463b-9e5e-26cc1dd9870d | Product name | 1 | 20230313 |
| c1c5a070-0e2e-43dd-af9c-a21585200342 | Product name | 1 | 20230104 |
| 2a463079-cd68-4798-a3d6-55c4c8578d57 | Product name | 1 | 20220728 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| 652f8f6b-479d-477c-848a-374d5b0145b7 | Product name | 2 | 20151203 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65219-332-95 | Adalimumab-aacf | 1 in 1 POUCH | SWAB | 2 | 0.75 g | 6 |
| 65219-618-02 | Adalimumab-aacf | 0.8 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1.6 mL | 40 mg in 0.8mL | 6 |
| 65219-620-20 | Adalimumab-aacf | 1 in 1 CARTON | KIT | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65219-620-20 | EA - Each | 65219-620 | 291e69fb-c360-4a55-add4-645014323710 | 1 | 2024-09-09 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2640864 | {4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector) } Pack | GPCK | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 2640869 | {6 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector) } Pack | GPCK | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 2640859 | adalimumab-aacf 40 MG in 0.8 ML Auto-Injector | PSN | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 2640851 | adalimumab-aacf 40 MG in 0.8 ML Prefilled Syringe | PSN | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 2640864 | adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (4 count) | PSN | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 2640869 | adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (6 count) | PSN | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 2640859 | 0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector | SCD | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 2640851 | 0.8 ML adalimumab-aacf 50 MG/ML Prefilled Syringe | SCD | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 2640859 | adalimumab-aacf 40 MG per 0.8 ML Auto-Injector | SY | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 2640851 | adalimumab-aacf 40 MG per 0.8 ML Prefilled Syringe | SY | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 2640864 | adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (4 count) | SY | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 2640869 | adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (6 count) | SY | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65219-332-95 | 65219033295 | 1 in 1 POUCH | Historical | ||||
| 65219-618-02 | 65219061802 | 0.8 mL in 1 SYRINGE, GLASS | 0.8 ml | Historical | |||
| 65219-620-20 | 65219062020 | 1 KIT in 1 CARTON (65219-620-20) * .8 mL in 1 SYRINGE, GLASS (65219-618-02) * 1 SWAB in 1 POUCH (65219-332-95) | 1 kit | 2024-06-30 | No | No | Historical |