Prescription drug · ANDA
Theophylline NDC 72789-442
Theophylline anhydrous 450 mg/1 · Tablet, Extended release · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-442-01 | 72789044201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-442-01)Marketed from Oct 16, 2024 |
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 — 450 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215312
- Marketing start
- Listing expires
- Other FDA classes
- Xanthines (Chemical structure)
- Identifiers
- Product ID 72789-442_57c5cb6d-297f-7b7c-e063-6294a90a93a9SPL ID 57c5cb6d-297f-7b7c-e063-6294a90a93a9SPL set ID 5e64036a-ee3e-42e7-9e59-881f88a4e298RxCUI 314241UNII 0I55128JYKUPC 0372789442013
- 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
N472789044201followed by a unit qualifier and the quantityPackage 72789-0442-01. 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 215312
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 300 mg/1 | Tablet, Extended releaseOral | Strides Pharma Science Limited | 64380-243 |
| Theophylline | Theophylline anhydrous 450 mg/1 | Tablet, Extended releaseOral | Strides Pharma Science Limited | 64380-244 |
| Theophylline | Theophylline anhydrous 300 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-441 |