Prescription drug · ANDA
Theophylline NDC 46708-025
Theophylline anhydrous 300 mg/1 · Tablet, Extended release · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-025-30 | 4670800253046708002530 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-30)Marketed from Nov 1, 2010 | |
| 46708-025-31 | 4670800253146708002531 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-31)Marketed from Nov 1, 2010 | |
| 46708-025-71 | 4670800257146708002571 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-71)Marketed from Nov 1, 2010 | |
| 46708-025-91 | 4670800259146708002591 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-91)Marketed from Nov 1, 2010 |
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
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090430
- Marketing start
- Listing expires
- Other FDA classes
- Xanthines (Chemical structure)
- Identifiers
- Product ID 46708-025_0d340b17-907e-4c38-bbd6-c4740495a55aSPL ID 0d340b17-907e-4c38-bbd6-c4740495a55aSPL set ID 31f3c720-1597-4d43-9296-33017b90b15fRxCUI 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
N446708002530followed by a unit qualifier and the quantityPackage 46708-0025-30. 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.
About NDC 46708-025
- What is NDC 46708-025?
- 46708-025 is the product NDC for Theophylline, Theophylline anhydrous 300 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Theophylline.
- What is the active ingredient?
- Theophylline anhydrous.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Theophylline?
- 40 other product NDCs are listed under this name. See all Theophylline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Theophylline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Theophylline | Theophylline anhydrous 300 mg/1 | Tablet, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-272 | 27241-0272-01 |
| Theophylline | Theophylline anhydrous 450 mg/1 | Tablet, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-273 | 27241-0273-01 |
| Theophylline | Theophylline anhydrous 300 mg/1 | Tablet, Extended releaseOral | Strides Pharma Science Limited | 64380-243 | 64380-0243-01 |
| Theophylline | Theophylline anhydrous 450 mg/1 | Tablet, Extended releaseOral | Strides Pharma Science Limited | 64380-244 | 64380-0244-01 |
| Theophylline | Theophylline anhydrous 300 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-441 | 72789-0441-01 |
| Theophylline | Theophylline anhydrous 450 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-442 | 72789-0442-01 |
| Theophylline | Theophylline anhydrous 300 mg/1 | Tablet, Extended releaseOral | Harman Finochem Limited | 82638-105 | 82638-0105-02 |
| Theophylline | Theophylline anhydrous 450 mg/1 | Tablet, Extended releaseOral | Harman Finochem Limited | 82638-106 | 82638-0106-02 |
| Theophylline | Theophylline anhydrous 300 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1782 | 70771-1782-01 |
| Theophylline | Theophylline anhydrous 450 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1783 | 70771-1783-01 |
Other NDCs under ANDA 090430
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 | Alembic Pharmaceuticals Limited | 46708-026 |
| Theophylline | Theophylline anhydrous 300 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-025 |
| Theophylline | Theophylline anhydrous 450 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-026 |