Ammonia
- Product NDC
- 49609-003
- 11-digit product format
- 496090003
- Labeler code
- 49609
- Product ID
- 49609-003_31e5cc40-daff-bea7-e063-6294a90a5aa4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMMONIA N-13
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- SOFIE Co. dba SOFIE
- Application
- ANDA203543
- Marketing category
- ANDA
- Marketing start
- 2011-08-04
- 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
- Brand name suffix
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49609-003-01 | AmmoniaN 13 | 30 mL in 1 VIAL, GLASS | INJECTION | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49609-003 | AMMONIA N 13 (AMMONIA N-13) INJECTION [SOFIE CO. DBA SOFIE] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250406_85882893-0661-46c2-a5f2-a73f6ea4fb5a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49609-003-01 | 49609000301 | 30 mL in 1 VIAL, GLASS (49609-003-01) | 30 ml | 2011-08-04 | 0000-00-00 | No | No | Current |