AMMONIA N-13
- Product NDC
- 52768-100
- 11-digit product format
- 527680100
- Labeler code
- 52768
- Product ID
- 52768-100_318c2020-f260-4b67-8df3-95ee2cf2b49e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMMONIA N-13
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Precision Nuclear LLC
- Application
- ANDA204547
- Marketing category
- ANDA
- Marketing start
- 2010-10-10
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52768-100-03 | AMMONIA N-13 | 3 mL in 1 SYRINGE | INJECTION, SOLUTION | 3 | | 11 |
| 52768-100-05 | AMMONIA N-13 | 5 mL in 1 SYRINGE | INJECTION, SOLUTION | 5 | | 11 |
| 52768-100-30 | AMMONIA N-13 | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 30 | | 11 |
| 52768-100-50 | AMMONIA N-13 | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52768-100 | AMMONIA N-13 INJECTION, SOLUTION [PRECISION NUCLEAR LLC] | 11 | Current NDC, Legacy NDC, 4 package rows | 20241222_cc430bfd-6940-41ca-bda4-6d29eb4dc1f2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52768-100-03 | 52768010003 | 3 mL in 1 SYRINGE (52768-100-03) | 3 ml | 2017-10-01 | 0000-00-00 | No | No | Current |
| 52768-100-05 | 52768010005 | 5 mL in 1 SYRINGE (52768-100-05) | 5 ml | 2017-10-01 | 0000-00-00 | No | No | Current |
| 52768-100-30 | 52768010030 | 30 mL in 1 VIAL, MULTI-DOSE (52768-100-30) | 30 ml | 2010-10-10 | 0000-00-00 | No | No | Current |
| 52768-100-50 | 52768010050 | 50 mL in 1 VIAL, MULTI-DOSE (52768-100-50) | 50 ml | 2010-10-10 | 0000-00-00 | No | No | Current |