Prescription drug · ANDA
Theophylline (Anhydrous) (Theophylline anhydrous) NDC 69367-415
Theophylline anhydrous 600 mg/1 · Tablet, Extended release · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-415-01 | 6936704150169367041501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-415-01)Marketed from Nov 25, 2025 |
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
- Westminster Pharmaceuticals, LLCNDC labeler code 69367
- 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 69367-415_46766222-63b4-478f-aa8b-a23b20476317SPL ID 46766222-63b4-478f-aa8b-a23b20476317SPL set ID 04f1d1da-ce61-45b3-acf4-903cc81d16daRxCUI 313291, 348472UNII 0I55128JYKUPC 0369367414012, 0369367415019
- 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
N469367041501followed by a unit qualifier and the quantityPackage 69367-0415-01. 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.
About NDC 69367-415
- What is NDC 69367-415?
- 69367-415 is the product NDC for Theophylline (Anhydrous) (theophylline anhydrous), Theophylline anhydrous 600 mg/1 tablet, extended release, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Theophylline (Anhydrous) (Theophylline Anhydrous).
- What is the active ingredient?
- Theophylline anhydrous.
- Who is the labeler?
- Westminster Pharmaceuticals, LLC, NDC labeler code 69367. 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 (Anhydrous)?
- 5 other product NDCs are listed under this name. See all Theophylline (Anhydrous) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Theophylline (Anhydrous) 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 (Anhydrous)theophylline anhydrous | Theophylline anhydrous 400 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-414 | 69367-0414-01 |
| Theophylline (Anhydrous)theophylline anhydrous | Theophylline anhydrous 400 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-941 | 82804-0941-0082804-0941-3082804-0941-60+2 more |
| Theophylline (Anhydrous)theophylline anhydrous | Theophylline anhydrous 600 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-942 | 82804-0942-0082804-0942-3082804-0942-60+2 more |
| Theophylline (Anhydrous)theophylline | Theophylline anhydrous 400 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-318 | 51407-0318-01 |
| Theophylline (Anhydrous)theophylline | Theophylline anhydrous 600 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-319 | 51407-0319-01 |
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 | 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 | Westminster Pharmaceuticals, LLC | 69367-414 |
| 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 |