Prescription drug · ANDA
Theophylline NDC 27808-033
Theophylline anhydrous 80 mg/15mL · Solution · Oral · Cranbury Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27808-033-01 | 2780800330127808003301 | 473 mL in 1 BOTTLE (27808-033-01)Marketed from Aug 2, 2012 |
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
- Cranbury Pharmaceuticals, LLCNDC labeler code 27808
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091586
- Marketing start
- Listing expires
- Other FDA classes
- Xanthines (Chemical structure)
- Identifiers
- Product ID 27808-033_723b1708-84c4-4a42-99bb-475c77bed2efSPL ID 723b1708-84c4-4a42-99bb-475c77bed2efSPL set ID 78a99bfe-6ebe-4ace-80b0-ee019921435eRxCUI 313306UNII 0I55128JYKUPC 0327808033017
- 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
N427808003301followed by a unit qualifier and the quantityPackage 27808-0033-01. 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 oral solution 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 27808-033
- What is NDC 27808-033?
- 27808-033 is the product NDC for Theophylline, Theophylline anhydrous 80 mg/15mL solution, listed with the FDA by Cranbury Pharmaceuticals, LLC. It has 1 package NDC, 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?
- Cranbury Pharmaceuticals, LLC, NDC labeler code 27808. 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 450 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-442 | 72789-0442-01 |
| Theophylline | Theophylline anhydrous 300 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-441 | 72789-0441-01 |
| 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 | 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 | Viona Pharmaceuticals Inc | 72578-173 | 72578-0173-01 |
| Theophylline | Theophylline anhydrous 450 mg/1 | Tablet, Extended releaseOral | Viona Pharmaceuticals Inc | 72578-174 | 72578-0174-01 |
Other NDCs under ANDA 091586
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 | ATLANTIC BIOLOGICALS CORP. | 17856-0038 |
| Theophylline | Theophylline anhydrous 80 mg/15mL | SolutionOral | Bryant Ranch Prepack | 71335-2909 |
| Theophylline | Theophylline anhydrous 80 mg/15mL | SolutionOral | Bryant Ranch Prepack | 72162-2038 |