Prescription drug · ANDA
Aminophylline NDC 0409-5921
Aminophylline dihydrate 25 mg/mL · Injection, Solution · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-5921-01 | 00409592101 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-5921-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-5921-16)Marketed from May 10, 2005 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Aminophylline
- Generic name (nonproprietary)
- aminophylline
- Active ingredients
- Aminophylline dihydrate — 25 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087242
- Marketing start
- Listing expires
- Other FDA classes
- Xanthines (Chemical structure)
- Identifiers
- Product ID 0409-5921_a36bc745-4366-4883-8e7d-4df241a069c4SPL ID a36bc745-4366-4883-8e7d-4df241a069c4SPL set ID 9a663ef3-881f-48bd-2689-3713b24545c2RxCUI 1724666, 1724668UNII C229N9DX94
- Pharmacologic class
- Methylxanthine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400409592101followed by a unit qualifier and the quantityPackage 00409-5921-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Intravenous theophylline is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 087242
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Aminophylline | Aminophylline dihydrate 25 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7060 |
| Aminophylline | Aminophylline dihydrate 25 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7374 |
| Aminophylline | Aminophylline dihydrate 25 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-5922 |
| Aminophylline | Aminophylline dihydrate 25 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1204 |
| Aminophylline | Aminophylline dihydrate 25 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1341 |
| Aminophylline | Aminophylline dihydrate 25 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9813 |
| Aminophylline | Aminophylline dihydrate 25 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9814 |
| Aminophylline | Aminophylline dihydrate 25 mg/mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-922 |