Prescription drug · ANDA
Armodafinil NDC 71335-1193
Armodafinil 150 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1193-1 | 7133511930171335119301 | 30 TABLET in 1 BOTTLE (71335-1193-1)Marketed from Apr 16, 2019 | |
| 71335-1193-2 | 7133511930271335119302 | 28 TABLET in 1 BOTTLE (71335-1193-2)Marketed from Apr 3, 2024 | |
| 71335-1193-3 | 7133511930371335119303 | 90 TABLET in 1 BOTTLE (71335-1193-3)Marketed from Apr 3, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Armodafinil
- Generic name (nonproprietary)
- armodafinil
- Active ingredients
- Armodafinil — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206069
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 71335-1193_0c5145ed-6785-4545-b59e-dc5ba22a07dcSPL ID 0c5145ed-6785-4545-b59e-dc5ba22a07dcSPL set ID cbe7c0d9-dfd2-4000-bd76-7fe3454ce64fRxCUI 724859, 724861UNII V63XWA605I
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
N471335119301followed by a unit qualifier and the quantityPackage 71335-1193-01. 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 .
Indications (excerpt from the label)
Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness. Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive s…
Excerpt only. Read the full label for complete information.
About NDC 71335-1193
- What is NDC 71335-1193?
- 71335-1193 is the product NDC for Armodafinil, Armodafinil 150 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Armodafinil.
- What is the active ingredient?
- Armodafinil.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Armodafinil?
- 27 other product NDCs are listed under this name. See all Armodafinil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Armodafinil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Armodafinil | Armodafinil 50 mg/1 | TabletOral | Direct_Rx | 72189-464 | 72189-0464-30 |
| Armodafinil | Armodafinil 50 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-177 | 69339-0177-0369339-0177-10 |
| Armodafinil | Armodafinil 150 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-178 | 69339-0178-0369339-0178-10 |
| Armodafinil | Armodafinil 200 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-179 | 69339-0179-0369339-0179-10 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-180 | 69339-0180-0369339-0180-05 |
| Armodafinil | Armodafinil 200 mg/1 | TabletOral | DirectRx | 72189-353 | 72189-0353-30 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | direct rx | 72189-261 | 72189-0261-30 |
| Armodafinil | Armodafinil 150 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7880 | 68788-7880-0368788-7880-0668788-7880-09 |
| Armodafinil | Armodafinil 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7826 | 68788-7826-0368788-7826-0668788-7826-09 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | direct rx | 72189-133 | 72189-0133-30 |
Other NDCs under ANDA 206069
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 |
|---|---|---|---|---|
| Armodafinil | Armodafinil 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-805 |
| Armodafinil | Armodafinil 150 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-806 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-807 |
| Armodafinil | Armodafinil 200 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-998 |
| Armodafinil | Armodafinil 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7826 |
| Armodafinil | Armodafinil 150 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7880 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1308 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | direct rx | 72189-133 |
| Armodafinil | Armodafinil 50 mg/1 | TabletOral | Direct_Rx | 72189-464 |