Prescription drug · ANDA
Theophylline NDC 27241-272
Theophylline anhydrous 300 mg/1 · Tablet, Extended release · Oral · Ajanta Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27241-272-01 | 27241027201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-272-01)Marketed from Mar 26, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Theophylline
- Generic name (nonproprietary)
- theophylline
- Active ingredients
- Theophylline anhydrous — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Ajanta Pharma USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218401
- Marketing start
- Listing expires
- Other FDA classes
- Xanthines (Chemical structure)
- Identifiers
- Product ID 27241-272_fbec14fb-bd76-48e7-b61f-b19cd1a3ea2fSPL ID fbec14fb-bd76-48e7-b61f-b19cd1a3ea2fSPL set ID 7a422c32-bbdf-4297-84f4-9c438c904b0cRxCUI 314241, 317769UNII 0I55128JYKUPC 0327241273018, 0327241272011
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N427241027201followed by a unit qualifier and the quantityPackage 27241-0272-01. 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 Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic 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 218401
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 |
|---|---|---|---|---|
| Theophylline | Theophylline anhydrous 450 mg/1 | Tablet, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-273 |