SAJAZIR
- Product NDC
- 70709-013
- 11-digit product format
- 707090013
- Labeler code
- 70709
- Product ID
- 70709-013_98f58ca8-04a0-4453-adf0-b000d3bcfae1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ICATIBANT
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Cycle Pharmaceuticals Ltd-Uk
- Application
- ANDA212446
- Marketing category
- ANDA
- Marketing start
- 2021-06-03
- Substance
- ICATIBANT ACETATE
- Active strength
- 30 mg/3mL
- Pharmacologic classes
- Bradykinin B2 Receptor Antagonist [EPC], Bradykinin B2 Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SAJAZIR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ICATIBANT ACETATE | 30 mg/3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 325O8467XK |
| Rxcui | 1148141, 2569480 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70709-013-01 | SAJAZIR | 3 mL in 1 SYRINGE, GLASS | INJECTION | 3 | | 5 |
| 70709-013-01 | SAJAZIR | 1 in 1 CARTON | INJECTION | 1 | | 5 |
| 70709-013-03 | SAJAZIR | 3 in 1 CARTON | INJECTION | 3 | | 5 |
| 70709-013-03 | SAJAZIR | 3 mL in 1 SYRINGE, GLASS | INJECTION | 3 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70709-013 | SAJAZIR (ICATIBANT) INJECTION [CYCLE PHARMACEUTICALS LTD-UK] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240524_1756aca0-21a1-4898-8d6c-9666738db45c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70709-013-01 | 70709001301 | 1 SYRINGE, GLASS in 1 CARTON (70709-013-01) / 3 mL in 1 SYRINGE, GLASS | 2021-06-03 | 0000-00-00 | No | No | Current |
| 70709-013-03 | 70709001303 | 3 SYRINGE, GLASS in 1 CARTON (70709-013-03) / 3 mL in 1 SYRINGE, GLASS | 2021-06-03 | 0000-00-00 | No | No | Current |