Ammonia N 13
- Product NDC
- 73410-001
- 11-digit product format
- 734100001
- Labeler code
- 73410
- Product ID
- 73410-001_31be36fd-e20b-e449-e063-6294a90aec4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ammonia N 13
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- SOFIE Co. dba SOFIE
- Application
- ANDA204465
- Marketing category
- ANDA
- Marketing start
- 2019-11-06
- Substance
- AMMONIA N-13
- Active strength
- 37.5 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 | 37.5 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 |
|---|
| 73410-001-01 | Ammonia N 13 | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73410-001 | AMMONIA N 13 INJECTION [SOFIE CO. DBA SOFIE] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250403_d24f8595-2231-4f15-ac2b-9148ec453324.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 73410-001-01 | 73410000101 | 30 mL in 1 VIAL, MULTI-DOSE (73410-001-01) | 30 ml | 2019-11-06 | 0000-00-00 | No | No | Current |