Prescription drug · ANDA
Theo-24 (Theophylline anhydrous) NDC 52244-200
Theophylline anhydrous 200 mg/1 · Capsule, Extended release · Oral · ENDO USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52244-200-10 | 5224402001052244020010 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-200-10)Marketed from Aug 25, 2014 |
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)
- Theo-24
- Generic name (nonproprietary)
- theophylline anhydrous
- Active ingredients
- Theophylline anhydrous — 200 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- ENDO USA, Inc.NDC labeler code 52244
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087943
- Marketing start
- Listing expires
- Other FDA classes
- Xanthines (Chemical structure)
- Identifiers
- Product ID 52244-200_95d19693-50ba-43fc-81fe-6cddc537703aSPL ID 95d19693-50ba-43fc-81fe-6cddc537703aSPL set ID 7a108fa0-c230-475f-be93-6f864b98a410RxCUI 198264, 313272, 313310, 701712, 844590, 844591, 844813, 844829UNII 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
N452244020010followed by a unit qualifier and the quantityPackage 52244-0200-10. 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.
About NDC 52244-200
- What is NDC 52244-200?
- 52244-200 is the product NDC for Theo-24 (theophylline anhydrous), Theophylline anhydrous 200 mg/1 capsule, extended release, listed with the FDA by ENDO USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Theo-24 (Theophylline anhydrous).
- What is the active ingredient?
- Theophylline anhydrous.
- Who is the labeler?
- ENDO USA, Inc., NDC labeler code 52244. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Theo-24?
- 3 other product NDCs are listed under this name. See all Theo-24 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Theo-24 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Theo-24theophylline anhydrous | Theophylline anhydrous 100 mg/1 | Capsule, Extended releaseOral | ENDO USA, Inc. | 52244-100 | 52244-0100-10 |
| Theo-24theophylline anhydrous | Theophylline anhydrous 300 mg/1 | Capsule, Extended releaseOral | ENDO USA, Inc. | 52244-300 | 52244-0300-10 |
| Theo-24theophylline anhydrous | Theophylline anhydrous 400 mg/1 | Capsule, Extended releaseOral | ENDO USA, Inc. | 52244-400 | 52244-0400-10 |