Adalimumab
- Product NDC
- 83257-021
- 11-digit product format
- 832570021
- Labeler code
- 83257
- Product ID
- 83257-021_ce598802-5148-0115-bd4c-fea7dd51fb90
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- adalimumab-fkjp
- Dosage form
- KIT
- Labeler
- Biocon Biologics Inc
- Application
- BLA761154
- Marketing category
- BLA
- Marketing start
- 2024-04-15
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Adalimumab
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 797544, 2640404, 2640412, 2640417 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
| 652f8f6b-479d-477c-848a-374d5b0145b7 | Product name | 2 | 20151203 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83257-021-42 | Adalimumab | 1 in 1 TRAY | KIT | 1 | 4 | |
| 83257-021-42 | Adalimumab | 2 in 1 KIT | KIT | 2 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83257-021-42 | EA - Each | 83257-021 | 2198b1ac-789d-4de5-9ce1-3c8f3c6eca3a | 1 | 2024-07-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2640412 | adalimumab-fkjp 20 MG in 0.4 ML Prefilled Syringe | PSN | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 2640404 | adalimumab-fkjp 40 MG in 0.8 ML Auto-Injector | PSN | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 2640417 | adalimumab-fkjp 40 MG in 0.8 ML Prefilled Syringe | PSN | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 2640412 | 0.4 ML adalimumab-fkjp 50 MG/ML Prefilled Syringe | SCD | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 2640404 | 0.8 ML adalimumab-fkjp 50 MG/ML Auto-Injector | SCD | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 2640417 | 0.8 ML adalimumab-fkjp 50 MG/ML Prefilled Syringe | SCD | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 2640412 | adalimumab-fkjp 20 MG per 0.4 ML Prefilled Syringe | SY | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 2640404 | adalimumab-fkjp 40 MG per 0.8 ML Auto-Injector | SY | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 2640417 | adalimumab-fkjp 40 MG per 0.8 ML Prefilled Syringe | SY | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | 5cde907d-6747-0e62-db25-1718ee717fe7 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83257-021-42 | 83257002142 | 2 TRAY in 1 KIT (83257-021-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET | 2 tray | 2024-04-15 | No | No | Current |