Prescription drug · ANDA
Alprazolam NDC 49884-110
Alprazolam .25 mg/1 · Tablet, Orally disintegrating · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-110-74 | 4988401107449884011074 | 10 BLISTER PACK in 1 CARTON (49884-110-74) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jan 9, 2009 |
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 — .25 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 49884
- 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 49884-110_38e94d5e-f7e2-4349-94f2-2fba605f5ae6SPL ID 38e94d5e-f7e2-4349-94f2-2fba605f5ae6SPL set ID ff1630b4-2044-433c-96bc-0bb4ae8d42a0RxCUI 485413, 485414, 485415, 485416UNII 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
N449884011074followed by a unit qualifier and the quantityPackage 49884-0110-74. 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 orally disintegrating tablets are a benzodiazepine indicated for: The treatment of generalized anxiety disorder ( 1.1 ). The efficacy of alprazolam was demonstrated in 5 short-term, placebo-controlled trials ( 14 ). The treatment of panic disorder, with or without agoraphobia ( 1.2 ). The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials ( 14 ). 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 t…
Excerpt only. Read the full label for complete information.
About NDC 49884-110
- What is NDC 49884-110?
- 49884-110 is the product NDC for Alprazolam, Alprazolam .25 mg/1 tablet, orally disintegrating, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, 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?
- Par Health USA, LLC, NDC labeler code 49884. 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 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 .5 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-111 |
| 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 ODT C-IV | Alprazolam .5 mg/1 | Tablet, Orally disintegratingOral | Direct_Rx | 72189-637 |