Ammonia
- Product NDC
- 76451-013
- 11-digit product format
- 764510013
- Labeler code
- 76451
- Product ID
- 76451-013_47d37f1c-3d95-ec07-e063-6394a90a8d2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMMONIA N-13
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- 3D Imaging Drug Design and Development LLC
- Application
- ANDA203779
- Marketing category
- ANDA
- Marketing start
- 2012-01-02
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ammonia
- Brand name suffix
- N 13
- Listing expiration
- 2027-12-31
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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76451-013-10 | AmmoniaN 13 | 10 mL in 1 VIAL, GLASS | INJECTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76451-013 | AMMONIA N 13 (AMMONIA N-13) INJECTION [3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20190214_fce62c22-a1e2-4193-8de5-e1961d9b94a5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76451-013-10 | 76451001310 | 10 mL in 1 VIAL, GLASS (76451-013-10) | 10 ml | 2018-12-17 | 0000-00-00 | No | No | Current |
| 76451-013-11 | 76451001311 | 10 mL in 1 SYRINGE, PLASTIC (76451-013-11) | 10 ml | 2018-12-17 | 0000-00-00 | No | No | Current |
| 76451-013-51 | 76451001351 | 5 mL in 1 SYRINGE, PLASTIC (76451-013-51) | 5 ml | 2018-12-17 | 0000-00-00 | No | No | Current |