Prescription drug · ANDA
Theophylline NDC 70771-1783
Theophylline anhydrous 450 mg/1 · Tablet, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1783-1 | 70771178301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1783-1)Marketed from May 25, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218063
- Marketing start
- Listing expires
- Other FDA classes
- Xanthines (Chemical structure)
- Identifiers
- Product ID 70771-1783_86fdabb8-c881-4695-8127-59b26998e365SPL ID 86fdabb8-c881-4695-8127-59b26998e365SPL set ID 7339f98d-b996-4e20-a7a7-315fd2a9fa4dRxCUI 314241, 317769UNII 0I55128JYK
- 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
N470771178301followed by a unit qualifier and the quantityPackage 70771-1783-01. 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 .
Other NDCs under ANDA 218063
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 | Zydus Lifesciences Limited | 70771-1782 |
| Theophylline | Theophylline anhydrous 300 mg/1 | Tablet, Extended releaseOral | Viona Pharmaceuticals Inc | 72578-173 |
| Theophylline | Theophylline anhydrous 450 mg/1 | Tablet, Extended releaseOral | Viona Pharmaceuticals Inc | 72578-174 |