Kit for the Preparation of Technetium Tc99m Mertiatide
- Product NDC
- 45567-0655
- 11-digit product format
- 455670655
- Labeler code
- 45567
- Product ID
- 45567-0655_21ca1be3-2caf-535c-e063-6394a90a18e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betiatide
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA208994
- Marketing category
- ANDA
- Marketing start
- 2019-09-02
- Substance
- BETIATIDE
- Active strength
- 1 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Kit for the Preparation of Technetium Tc99m Mertiatide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BETIATIDE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9NV2SR34P8 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45567-0655-1 | Kit for the Preparation of Technetium Tc99m Mertiatide | 5 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45567-0655 | KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE (BETIATIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240912_0ad62039-f848-4f3d-b489-2524e6b6b86e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45567-0655-1 | 45567065501 | 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (45567-0655-1) | 2019-09-02 | 0000-00-00 | No | No | Current |