ICATIBANT
- Product NDC
- 69097-664
- 11-digit product format
- 690970664
- Labeler code
- 69097
- Product ID
- 69097-664_430ca904-a971-4233-a98b-46ca19275dab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ICATIBANT
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Cipla USA Inc.
- Application
- ANDA212446
- Marketing category
- ANDA
- Marketing start
- 2020-07-13
- 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
- ICATIBANT
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-664-34 | ICATIBANT | 1 in 1 CARTON | INJECTION | 1 | | 6 |
| 69097-664-34 | ICATIBANT | 3 mL in 1 SYRINGE, GLASS | INJECTION | 3 | | 6 |
| 69097-664-68 | ICATIBANT | 3 mL in 1 SYRINGE, GLASS | INJECTION | 3 | | 6 |
| 69097-664-68 | ICATIBANT | 3 in 1 CARTON | INJECTION | 3 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-664 | ICATIBANT INJECTION [CIPLA USA INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240524_ccbb5e50-ce56-4898-aa1a-f1c1f3d312f6.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 |
|---|
| 69097-664-34 | 69097066434 | 1 SYRINGE, GLASS in 1 CARTON (69097-664-34) / 3 mL in 1 SYRINGE, GLASS | 2020-07-13 | 0000-00-00 | No | No | Current |
| 69097-664-68 | 69097066468 | 3 SYRINGE, GLASS in 1 CARTON (69097-664-68) / 3 mL in 1 SYRINGE, GLASS | 2020-07-13 | 0000-00-00 | No | No | Current |