Prescription drug · ANDA
Theophylline (Anhydrous) (theophylline) NDC 51407-318
Theophylline anhydrous 400 mg/1 · Tablet, Extended release · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-318-01 | 51407031801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-318-01)Marketed from Jan 30, 2020 |
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 (Anhydrous)Suffix: (Anhydrous)
- Generic name (nonproprietary)
- theophylline
- Active ingredients
- Theophylline anhydrous — 400 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040560
- Marketing start
- Marketing end
- Other FDA classes
- Xanthines (Chemical structure)
- Identifiers
- Product ID 51407-318_52d3ddeb-83fd-f850-e063-6394a90a1cb7SPL ID 52d3ddeb-83fd-f850-e063-6394a90a1cb7SPL set ID aa80b9f4-8a5d-3e14-e053-2a95a90a8aabRxCUI 313291, 348472UNII 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
N451407031801followed by a unit qualifier and the quantityPackage 51407-0318-01. 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 is 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 040560
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 (Anhydrous)theophylline anhydrous | Theophylline anhydrous 400 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-414 |
| Theophylline (Anhydrous)theophylline anhydrous | Theophylline anhydrous 600 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-415 |
| Theophylline (Anhydrous)theophylline | Theophylline anhydrous 600 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-319 |
| Theophylline (Anhydrous)theophylline anhydrous | Theophylline anhydrous 400 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-941 |
| Theophylline (Anhydrous)theophylline anhydrous | Theophylline anhydrous 600 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-942 |