Prescription drug · ANDA
Oxazepam NDC 69315-913
Oxazepam 30 mg/1 · Capsule · Oral · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-913-01 | 69315091301 | 100 CAPSULE in 1 BOTTLE (69315-913-01)Marketed from Jul 9, 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)
- Oxazepam
- Generic name (nonproprietary)
- oxazepam
- Active ingredients
- Oxazepam — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Leading Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218261
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 69315-913_708e4237-a898-4d23-90b1-253c18301884SPL ID 708e4237-a898-4d23-90b1-253c18301884SPL set ID 67f821fa-5663-4d69-82c9-5ee13a09f324RxCUI 198057, 198059, 312134UNII 6GOW6DWN2AUPC 0369315913017
- 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
N469315091301followed by a unit qualifier and the quantityPackage 69315-0913-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS Oxazepam capsules are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Anxiety associated with depression is also responsive to oxazepam therapy. This product has been found particularly useful in the management of anxiety, tension, agitation and irritability in older patients. Alcoholics with acute tremulousness, inebriation, or with anxiety associated with alcohol withdrawal are responsive to therapy. The effectiveness of oxazepam in long-term use, that is, more than 4 months, has not been assessed by sys…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218261
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.