Ammonia
- Product NDC
- 47584-003
- 11-digit product format
- 475840003
- Labeler code
- 47584
- Product ID
- 47584-003_7cdaca5b-7ca2-8abd-e053-2a91aa0aaa7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMMONIA N-13
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Houston Cyclotron Partners LP dba Cyclotope
- Application
- ANDA203543
- Marketing category
- ANDA
- Marketing start
- 2011-08-04
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record