Prescription drug · ANDA
Eszopiclone NDC 47335-588
Eszopiclone 3 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-588-08 | 47335058808 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-588-08)Marketed from Apr 15, 2014 | |
| 47335-588-18 | 47335058818 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-588-18)Marketed from Apr 15, 2014 | |
| 47335-588-83 | 47335058883 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-588-83)Marketed from Apr 15, 2014 | |
| 47335-588-88 | 47335058888 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-588-88)Marketed from Apr 15, 2014 |
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)
- Eszopiclone
- Generic name (nonproprietary)
- eszopiclone
- Active ingredients
- Eszopiclone — 3 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091103
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 47335-588_95e952a3-5a7d-4b4c-9ac8-b5256a4371c3SPL ID 95e952a3-5a7d-4b4c-9ac8-b5256a4371c3SPL set ID 8bb1965e-7845-4c5b-b021-38e251303d68RxCUI 485440, 485442, 485465UNII UZX80K71OEUPC 0347335586831
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
N447335058808followed by a unit qualifier and the quantityPackage 47335-0588-08. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 47335-588
- What is NDC 47335-588?
- 47335-588 is the product NDC for Eszopiclone, Eszopiclone 3 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eszopiclone.
- What is the active ingredient?
- Eszopiclone.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eszopiclone?
- 88 other product NDCs are listed under this name. See all Eszopiclone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eszopiclone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4398 | 70518-4398-00 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4361 | 70518-4361-0070518-4361-01 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8826 | 68788-8826-0368788-8826-06 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0407 | 80425-0407-0180425-0407-0280425-0407-03 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-855 | 31722-0855-0131722-0855-30 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-856 | 31722-0856-0131722-0856-30 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-857 | 31722-0857-0131722-0857-30 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-159 | 82804-0159-3082804-0159-6082804-0159-90 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8387 | 68788-8387-0368788-8387-06 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3576 | 70518-3576-0070518-3576-0170518-3576-02 |
Other NDCs under ANDA 091103
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 |
|---|---|---|---|---|
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-586 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-587 |