Prescription drug · ANDA
Oxazepam NDC 52817-290
Oxazepam 10 mg/1 · Capsule · Oral · TruPharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-290-10 | 5281702901052817029010 | 100 CAPSULE in 1 BOTTLE (52817-290-10)Marketed from Jun 1, 2021 |
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)
- Oxazepam
- Generic name (nonproprietary)
- oxazepam
- Active ingredients
- Oxazepam — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- TruPharma, LLCNDC labeler code 52817
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071026
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 52817-290_2a9ebd02-ff4a-2aa2-e063-6394a90a6fdeSPL ID 2a9ebd02-ff4a-2aa2-e063-6394a90a6fdeSPL set ID bda8bc70-3328-46f2-89d5-7ef7a061b418RxCUI 198057, 198059, 312134UNII 6GOW6DWN2AUPC 0352817292100, 0352817290106
- Pharmacologic class
- Benzodiazepine
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
N452817029010followed by a unit qualifier and the quantityPackage 52817-0290-10. 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 . This label includes a boxed warning.
About NDC 52817-290
- What is NDC 52817-290?
- 52817-290 is the product NDC for Oxazepam, Oxazepam 10 mg/1 capsule, listed with the FDA by TruPharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxazepam.
- What is the active ingredient?
- Oxazepam.
- Who is the labeler?
- TruPharma, LLC, NDC labeler code 52817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxazepam?
- 15 other product NDCs are listed under this name. See all Oxazepam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxazepam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxazepam | Oxazepam 10 mg/1 | CapsuleOral | Leading Pharma, LLC | 69315-911 | 69315-0911-01 |
| Oxazepam | Oxazepam 15 mg/1 | CapsuleOral | Leading Pharma, LLC | 69315-912 | 69315-0912-01 |
| Oxazepam | Oxazepam 30 mg/1 | CapsuleOral | Leading Pharma, LLC | 69315-913 | 69315-0913-01 |
| Oxazepam | Oxazepam 15 mg/1 | CapsuleOral | TruPharma, LLC | 52817-291 | 52817-0291-10 |
| Oxazepam | Oxazepam 30 mg/1 | CapsuleOral | TruPharma, LLC | 52817-292 | 52817-0292-10 |
| Oxazepam | Oxazepam 15 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-639 | 71610-0639-3071610-0639-5371610-0639-60 |
| Oxazepam | Oxazepam 10 mg/1 | Capsule, Gelatin coatedOral | American Health Packaging | 62584-812 | 62584-0812-01 |
| Oxazepam | Oxazepam 15 mg/1 | Capsule, Gelatin coatedOral | American Health Packaging | 62584-813 | 62584-0813-01 |
| Oxazepam | Oxazepam 30 mg/1 | Capsule, Gelatin coatedOral | American Health Packaging | 62584-814 | 62584-0814-01 |
| Oxazepam | Oxazepam 10 mg/1 | Capsule, Gelatin coatedOral | Actavis Pharma, Inc. | 0228-2067 | 00228-2067-10 |
Other NDCs under ANDA 071026
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 |
|---|---|---|---|---|
| Oxazepam | Oxazepam 15 mg/1 | CapsuleOral | TruPharma, LLC | 52817-291 |
| Oxazepam | Oxazepam 30 mg/1 | CapsuleOral | TruPharma, LLC | 52817-292 |
| Oxazepam | Oxazepam 15 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-639 |