OMLYCLO
- Product NDC
- 72606-054
- 11-digit product format
- 726060054
- Labeler code
- 72606
- Product ID
- 72606-054_0cfb7a85-6b8a-4530-aa3f-5a6aa7422d73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omalizumab-igec
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- CELLTRION USA, Inc.
- Application
- BLA761399
- Marketing category
- BLA
- Marketing start
- 2026-10-05
- Substance
- OMALIZUMAB
- Active strength
- 300 mg/2mL
- Pharmacologic classes
- Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OMLYCLO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMALIZUMAB | 300 mg/2mL |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761399 | Omlyclo | omalizumab-igec | 351(k) Interchangeable | Rx | 2026-09-01 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72606-054-01 | 72606005401 | 1 SYRINGE, GLASS in 1 CARTON (72606-054-01) / 2 mL in 1 SYRINGE, GLASS | 2026-10-05 | No | No | Current |
| 72606-054-02 | 72606005402 | 2 SYRINGE, GLASS in 1 CARTON (72606-054-02) / 2 mL in 1 SYRINGE, GLASS | 2026-10-05 | No | No | Current |