Ammonia
- Product NDC
- 65857-200
- 11-digit product format
- 658570200
- Labeler code
- 65857
- Product ID
- 65857-200_886dbcba-5cf9-4d8b-95c0-d4fc574e8e02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ammonia N-13
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Cardinal Health 414, LLC
- Application
- ANDA203700
- Marketing category
- ANDA
- Marketing start
- 2013-02-25
- 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
- Brand name suffix
- 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 |
|---|
| 65857-200-10 | AmmoniaN-13 | 10 mL in 1 VIAL, GLASS | INJECTION | 10 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65857-200 | AMMONIA N-13 INJECTION [CARDINAL HEALTH 414, LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20180716_4c563174-c7cd-4224-b865-4da2f39c21c0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65857-200-10 | 65857020010 | 10 mL in 1 VIAL, GLASS (65857-200-10) | 10 ml | 2013-02-25 | 0000-00-00 | No | No | Current |