Prescription drug · ANDA
Theophylline (Anhydrous) (theophylline anhydrous) NDC 82804-942
Theophylline anhydrous 600 mg/1 · Tablet, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-942-00 | 82804094200 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-942-00)Marketed from Sep 17, 2026 | |
| 82804-942-30 | 82804094230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-942-30)Marketed from Sep 17, 2026 | |
| 82804-942-60 | 82804094260 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-942-60)Marketed from Sep 17, 2026 | |
| 82804-942-72 | 82804094272 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-942-72)Marketed from Sep 17, 2026 | |
| 82804-942-90 | 82804094290 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-942-90)Marketed from Sep 17, 2026 |
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 anhydrous
- Active ingredients
- Theophylline anhydrous — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040560
- Marketing start
- Listing expires
- Other FDA classes
- Xanthines (Chemical structure)
- Identifiers
- Product ID 82804-942_882657ae-e15b-4c86-a571-b55460bd4726SPL ID 882657ae-e15b-4c86-a571-b55460bd4726
- 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
N482804094200followed by a unit qualifier and the quantityPackage 82804-0942-00. 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
The FDA listing for this product does not reference a label (SPL) set.
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 400 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-318 |
| 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 |