Prescription drug · ANDA
Alprazolam NDC 69339-200
Alprazolam .5 mg/1 · Tablet · Oral · Natco Pharma USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69339-200-01 | 6933902000169339020001 | 100 TABLET in 1 BOTTLE (69339-200-01)Marketed from Jul 28, 2023 | |
| 69339-200-05 | 6933902000569339020005 | 500 TABLET in 1 BOTTLE (69339-200-05)Marketed from Jul 28, 2023 | |
| 69339-200-10 | 6933902001069339020010 | 1000 TABLET in 1 BOTTLE (69339-200-10)Marketed from Jul 28, 2023 |
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)
- Alprazolam
- Generic name (nonproprietary)
- alprazolam
- Active ingredients
- Alprazolam — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Natco Pharma USA LLCNDC labeler code 69339
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200739
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 69339-200_885d0fec-f1a6-42f4-8617-1d048cb15ee9SPL ID 885d0fec-f1a6-42f4-8617-1d048cb15ee9SPL set ID b3c55877-2538-4892-bdb1-d618c643d29cRxCUI 197321, 197322, 308047, 308048UNII YU55MQ3IZYUPC 0369339202012, 0369339199107, 0369339199053, 0369339199015, 0369339200018, 0369339201053, 0369339200056, 0369339201107, 0369339202104, 0369339202050, 0369339200100, 0369339201015
- 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
N469339020001followed by a unit qualifier and the quantityPackage 69339-0200-01. 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)
Alprazolam tablets are indicated for the: acute treatment of generalized anxiety disorder (GAD) in adults. treatment of panic disorder (PD), with or without agoraphobia in adults. Alprazolam tablets is a benzodiazepine indicated for the: Acute treatment of generalized anxiety disorder in adults. ( 1 ) Treatment of panic disorder with or without agoraphobia in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 69339-200
- What is NDC 69339-200?
- 69339-200 is the product NDC for Alprazolam, Alprazolam .5 mg/1 tablet, listed with the FDA by Natco Pharma USA LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alprazolam.
- What is the active ingredient?
- Alprazolam.
- Who is the labeler?
- Natco Pharma USA LLC, NDC labeler code 69339. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alprazolam?
- 124 other product NDCs are listed under this name. See all Alprazolam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alprazolam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-360 | 29300-0360-0129300-0360-0529300-0360-10 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-361 | 29300-0361-0129300-0361-0529300-0361-10 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-362 | 29300-0362-0129300-0362-0529300-0362-10 |
| Alprazolam | Alprazolam 2 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-363 | 29300-0363-0129300-0363-0529300-0363-10 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Coupler LLC | 67046-0007 | 67046-0007-03 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Coupler LLC | 67046-0154 | 67046-0154-03 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | AvPAK | 50268-033 | 50268-0033-15 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | AvPAK | 50268-034 | 50268-0034-15 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | AvPAK | 50268-035 | 50268-0035-15 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0444 | 80425-0444-0180425-0444-02 |
Other NDCs under ANDA 200739
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 |
|---|---|---|---|---|
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-199 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-201 |
| Alprazolam | Alprazolam 2 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-202 |