Ammonia N 13
- Product NDC
- 69714-001
- 11-digit product format
- 697140001
- Labeler code
- 69714
- Product ID
- 69714-001_4139da22-38ae-8910-e063-6394a90ad510
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NH3N13
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- University of Alabama at Birmingham
- Application
- ANDA211698
- Marketing category
- ANDA
- Marketing start
- 2018-10-01
- 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 |
|---|
| 69714-001-10 | Ammonia N 13 | 10 mL in 1 VIAL, GLASS | INJECTION | 10 | | 7 |
| 69714-001-10 | Ammonia N 13 | 1 in 1 CONTAINER | INJECTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69714-001 | AMMONIA N 13 (NH3N13) INJECTION [UNIVERSITY OF ALABAMA AT BIRMINGHAM] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241023_bbc03271-8d23-4e89-aa32-cff581cdc275.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69714-001-01 | 69714000101 | 4 mL in 1 VIAL, GLASS (69714-001-01) | 4 ml | 2018-10-01 | 0000-00-00 | No | No | Current |
| 69714-001-10 | 69714000110 | 1 VIAL, GLASS in 1 CONTAINER (69714-001-10) / 10 mL in 1 VIAL, GLASS | | 2018-10-01 | | No | No | Current |