Kit for the Preparation of Indium In 111 Pentetreotide
- Product NDC
- 45567-0755
- 11-digit product format
- 455670755
- Labeler code
- 45567
- Product ID
- 45567-0755_334fde6d-c2c2-0054-e063-6394a90a26f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indium In-111 Pentetreotide
- Dosage form
- KIT
- Route
- INTRAVENOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA212785
- Marketing category
- ANDA
- Marketing start
- 2025-03-25
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45567-0753-1 | Kit for the Preparation of Indium In 111 Pentetreotide | 1 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 mL | 10 ug in 1mL | 12 |
| 45567-0755-3 | Kit for the Preparation of Indium In 111 Pentetreotide | 1 in 1 KIT | KIT | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45567-0755 | KIT FOR THE PREPARATION OF INDIUM IN 111 PENTETREOTIDE (INDIUM IN-111 PENTETREOTIDE) KIT [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 12 | Current NDC, 2 package rows | 20250424_e2117bbd-9db3-4d20-a5da-89551c18a0cb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 45567-0753-1 | 45567075301 | 1 mL in 1 VIAL | 1 ml | | | | Historical |
| 45567-0755-3 | 45567075503 | 1 KIT in 1 KIT (45567-0755-3) * 1 mL in 1 VIAL (45567-0752-1) * 1 mL in 1 VIAL (45567-0753-1) | 1 kit | 2025-03-25 | No | No | Historical |