Prescription drug · ANDA
Alprazolam ODT C-IV NDC 72189-637
Alprazolam .5 mg/1 · Tablet, Orally disintegrating · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-637-02 | 72189063702 | 2 TABLET, ORALLY DISINTEGRATING in 1 CARTON (72189-637-02)Marketed from Aug 22, 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)
- Alprazolam ODT C-IV
- Generic name (nonproprietary)
- alprazolam odt c-iv
- Active ingredients
- Alprazolam — .5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078088
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 72189-637_4d3aab18-54e7-cb65-e063-6394a90a9b26SPL ID 4d3aab18-54e7-cb65-e063-6394a90a9b26SPL set ID 3cf95203-c8b4-9f06-e063-6394a90abc9cRxCUI 485415UNII YU55MQ3IZY
- 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
N472189063702followed by a unit qualifier and the quantityPackage 72189-0637-02. 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)
1.1 Generalized Anxiety Disorder Alprazolam orally disintegrating tablets, USP are indicated for the treatment of generalized anxiety disorder. The efficacy of alprazolam in the treatment of generalized anxiety disorder was demonstrated in 5 short-term, placebo-controlled trials [see Clinical Studies (14.1)]. 1.2 Panic Disorder Alprazolam orally disintegrating tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials [see Clinical Studies (14.2)]. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078088
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 1 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-213 |
| Alprazolam | Alprazolam 2 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-214 |
| Alprazolam | Alprazolam .5 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-111 |
| Alprazolam | Alprazolam .25 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-110 |