Prescription drug · ANDA
Alprazolam NDC 43063-609
Alprazolam 1 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-609-30 | 4306306093043063060930 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-609-30)Marketed from Oct 6, 2015 | |
| 43063-609-40 | 4306306094043063060940 | 40 TABLET in 1 BOTTLE, PLASTIC (43063-609-40)Marketed from Oct 19, 2015 | |
| 43063-609-60 | 4306306096043063060960 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-609-60)Marketed from Sep 3, 2015 | |
| 43063-609-90 | 4306306099043063060990 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-609-90)Marketed from Sep 3, 2015 |
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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074112
- Marketing start
- Marketing end
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 43063-609_2f3aacb7-ebbb-e49e-e063-6394a90a9176SPL ID 2f3aacb7-ebbb-e49e-e063-6394a90a9176SPL set ID 0ffcdbab-17e4-4395-8155-5b6ad00be6c2RxCUI 197321UNII YU55MQ3IZYUPC 0343063609309
- 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
N443063060930followed by a unit qualifier and the quantityPackage 43063-0609-30. 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 are 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 43063-609
- What is NDC 43063-609?
- 43063-609 is the product NDC for Alprazolam, Alprazolam 1 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 4 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?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 074112
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 | Sandoz Inc | 0781-1061 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Sandoz Inc | 0781-1077 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Sandoz Inc | 0781-1079 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | A-S Medication Solutions | 50090-1864 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-2896 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Proficient Rx LP | 63187-225 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Proficient Rx LP | 63187-443 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Proficient Rx LP | 63187-916 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4137 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-696 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-734 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0100 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0284 |