Prescription drug · ANDA
Theophylline NDC 62332-026
Theophylline anhydrous 450 mg/1 · Tablet, Extended release · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-026-30 | 6233200263062332002630 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-026-30)Marketed from Jan 29, 2016 | |
| 62332-026-31 | 6233200263162332002631 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-026-31)Marketed from Jan 29, 2016 | |
| 62332-026-71 | 6233200267162332002671 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-026-71)Marketed from Jan 29, 2016 |
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
- Alembic Pharmaceuticals Inc.NDC labeler code 62332
- 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 62332-026_d9cbb2b7-6524-4587-9111-e3abfd2e888bSPL ID d9cbb2b7-6524-4587-9111-e3abfd2e888bSPL set ID 77e849b8-900b-4f0d-ac5c-1391abcd5721RxCUI 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
N462332002630followed by a unit qualifier and the quantityPackage 62332-0026-30. 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 62332-026
- What is NDC 62332-026?
- 62332-026 is the product NDC for Theophylline, Theophylline anhydrous 450 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 3 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 Inc., NDC labeler code 62332. 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 300 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-025 |
| 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 |