Ammonia N-13
- Product NDC
- 69864-002
- 11-digit product format
- 698640002
- Labeler code
- 69864
- Product ID
- 69864-002_0ce4c7b6-2913-fecf-e063-6394a90ab438
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ammonia N-13
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- The Methodist Hospital Research Institute
- Application
- ANDA215083
- Marketing category
- ANDA
- Marketing start
- 2021-07-09
- 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 |
|---|
| 69864-002-30 | Ammonia N-13 | 6 mL in 1 VIAL, GLASS | INJECTION | 6 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69864-002 | AMMONIA N-13 INJECTION [THE METHODIST HOSPITAL RESEARCH INSTITUTE] | 2 | Current NDC, Legacy NDC, 1 package rows | 20231227_c79222b1-7dd8-f1fe-e053-2a95a90a3639.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69864-002-30 | 69864000230 | 6 mL in 1 VIAL, GLASS (69864-002-30) | 6 ml | 2021-07-09 | 0000-00-00 | No | No | Current |