LANREOTIDE ACETATE
- Product NDC
- 70121-2517
- 11-digit product format
- 701212517
- Labeler code
- 70121
- Product ID
- 70121-2517_43b3c820-dda0-4514-92cd-3ad85019d105
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LANREOTIDE ACETATE
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA218217
- Marketing category
- ANDA
- Marketing start
- 2026-09-23
- Substance
- LANREOTIDE ACETATE
- Active strength
- 120 mg/.5mL
- Pharmacologic classes
- Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
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
- LANREOTIDE ACETATE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LANREOTIDE ACETATE | 120 mg/.5mL |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70121-2517-5 | 70121251705 | 1 POUCH in 1 CARTON (70121-2517-5) / 1 SYRINGE, PLASTIC in 1 POUCH / .5 mL in 1 SYRINGE, PLASTIC | 1 pouch | 2026-09-23 | No | No | Current |