Ammonia N 13
- Product NDC
- 76318-643
- 11-digit product format
- 763180643
- Labeler code
- 76318
- Product ID
- 76318-643_483561c7-747d-40a7-8ed7-134eac3da69c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ammonia n-13
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Massachusetts General Hospital
- Application
- ANDA207025
- Marketing category
- ANDA
- Marketing start
- 2016-02-03
- 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 |
|---|
| 76318-643-30 | Ammonia N 13 | 30 mL in 1 VIAL | INJECTION, SOLUTION | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76318-643 | AMMONIA N 13 (AMMONIA N-13) INJECTION, SOLUTION [MASSACHUSETTS GENERAL HOSPITAL] | 5 | Current NDC, Legacy NDC, 1 package rows | 20211126_57947a8c-939e-4468-805c-2f2001041fe4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76318-643-30 | 76318064330 | 30 mL in 1 VIAL (76318-643-30) | 30 ml | 2016-02-03 | 0000-00-00 | No | No | Current |