Prescription drug · ANDA
Theophylline NDC 62135-556
Theophylline anhydrous 80 mg/15mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-556-24 | 62135055624 | 2 TRAY in 1 BOX (62135-556-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (62135-556-51)Marketed from May 31, 2024 | |
| 62135-556-47 | 62135055647 | 473 mL in 1 BOTTLE (62135-556-47)Marketed from Oct 27, 2022 |
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 — 80 mg/15mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091156
- Marketing start
- Listing expires
- Other FDA classes
- Xanthines (Chemical structure)
- Identifiers
- Product ID 62135-556_4a2adbbe-acaa-a2bf-e063-6294a90a44c3SPL ID 4a2adbbe-acaa-a2bf-e063-6294a90a44c3SPL set ID 1b685384-5d96-46fa-b93b-e96538a2cfe7RxCUI 313306UNII 0I55128JYKUPC 0362135556471
- 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
N462135055624followed by a unit qualifier and the quantityPackage 62135-0556-24. 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 091156
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 80 mg/15mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-556 |