Prescription drug · ANDA
Modafinil NDC 70771-1051
Modafinil 100 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70771-1051Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1051Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1051-1 | 7077110510170771105101 | 100 TABLET in 1 BOTTLE (70771-1051-1)Marketed from Jan 4, 2018 | |
| 70771-1051-3 | 7077110510370771105103 | 30 TABLET in 1 BOTTLE (70771-1051-3)Marketed from Jan 4, 2018 | |
| 70771-1051-9 | 7077110510970771105109 | 90 TABLET in 1 BOTTLE (70771-1051-9)Marketed from Jan 4, 2018 |
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)
- Modafinil
- Generic name (nonproprietary)
- modafinil
- Active ingredients
- Modafinil — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209966
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 70771-1051_e22df34a-3c16-4062-9882-be9840afb8cfSPL ID e22df34a-3c16-4062-9882-be9840afb8cfSPL set ID f39820fb-8248-4d42-854c-6fe2d9b92d36RxCUI 205324, 260218UNII R3UK8X3U3DUPC 0372578006068
- Pharmacologic class
- Sympathomimetic-like Agent
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
N470771105101followed by a unit qualifier and the quantityPackage 70771-1051-01. 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 .
About NDC 70771-1051
- What is NDC 70771-1051?
- 70771-1051 is the product NDC for Modafinil, Modafinil 100 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Modafinil.
- What is the active ingredient?
- Modafinil.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Modafinil?
- 49 other product NDCs are listed under this name. See all Modafinil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Modafinil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Modafinil | Modafinil 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8653 | 68788-8653-0368788-8653-0668788-8653-09 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-862 | 23155-0862-0123155-0862-0323155-0862-05+1 more |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2501 | 71335-2501-0071335-2501-0171335-2501-02+7 more |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8280 | 68788-8280-0368788-8280-0668788-8280-09 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | Bionpharma Inc. | 69452-342 | 69452-0342-1369452-0342-1969452-0342-20 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Bionpharma Inc. | 69452-343 | 69452-0343-1369452-0343-1969452-0343-20 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-989 | 71610-0989-3071610-0989-5371610-0989-60 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-604 | 23155-0604-0123155-0604-0323155-0604-05+1 more |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-605 | 23155-0605-0123155-0605-0323155-0605-05+1 more |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2258 | 71335-2258-0071335-2258-0171335-2258-02+7 more |
Other NDCs under ANDA 209966
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 |
|---|---|---|---|---|
| Modafinil | Modafinil 100 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-960 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-961 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1052 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-873 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-976 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-991 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-005 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-006 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Proficient Rx LP | 82804-126 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-308 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-309 |