Ammonia N 13
- Product NDC
- 40028-514
- 11-digit product format
- 400280514
- Labeler code
- 40028
- Product ID
- 40028-514_4513e87e-72fd-96e1-e063-6394a90a9273
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ammonia N-13
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- PETNET Solutions, Inc.
- Application
- ANDA204510
- Marketing category
- ANDA
- Marketing start
- 2007-08-23
- Substance
- AMMONIA N-13
- Active strength
- 260 mCi/mL
- Pharmacologic classes
- Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ammonia N 13
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMMONIA N-13 | 260 mCi/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9OQO0E343Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 40028-514-50 | Ammonia N 13 | 50 mL in 1 VIAL, GLASS | INJECTION | 50 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 40028-514 | AMMONIA N 13 (AMMONIA N-13) INJECTION [PETNET SOLUTIONS, INC.] | 2 | Current NDC, 1 package rows | 20250416_b1559f8a-1fc8-4a9e-b4f4-5e2efcb1f12c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 40028-514-50 | 40028051450 | 50 mL in 1 VIAL, GLASS (40028-514-50) | 50 ml | 2025-02-01 | No | No | Historical |