IDACIO
- Product NDC
- 65219-558
- 11-digit product format
- 652190558
- Labeler code
- 65219
- Product ID
- 65219-558_08dbaffe-9d05-43cf-b24b-b44ade8685fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- adalimumab-aacf
- Dosage form
- KIT
- Labeler
- Fresenius Kabi USA, LLC
- Application
- BLA761255
- Marketing category
- BLA
- Marketing start
- 2024-12-09
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IDACIO
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 797544, 2699315, 2699319 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-332-95 | IDACIO | 1 in 1 POUCH | SWAB | 2 | 0.75 g | 1 |
| 65219-558-08 | IDACIO | 1 in 1 CARTON | KIT | 1 | | 1 |
| 65219-562-01 | IDACIO | 0.8 mL in 1 VIAL, GLASS | INJECTION | 0.8 mL | 40 mg in 0.8mL | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-558 | IDACIO (ADALIMUMAB-AACF) KIT [FRESENIUS KABI USA, LLC] | 1 | Current NDC, 3 package rows | 20241209_08dbaffe-9d05-43cf-b24b-b44ade8685fc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-332-95 | 65219033295 | 1 in 1 POUCH | | | | | Historical |
| 65219-558-08 | 65219055808 | 1 KIT in 1 CARTON (65219-558-08) * .8 mL in 1 VIAL, GLASS (65219-562-01) * 1 SWAB in 1 POUCH (65219-332-95) | 1 kit | 2024-12-09 | No | No | Current |
| 65219-562-01 | 65219056201 | 0.8 mL in 1 VIAL, GLASS | 0.8 ml | | | | Historical |