Prescription drug · ANDA
Eszopiclone NDC 71335-2002
Eszopiclone 3 mg/1 · Tablet, Film coated · Oropharyngeal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2002-1 | 71335200201 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2002-1)Marketed from Feb 10, 2022 | |
| 71335-2002-2 | 71335200202 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2002-2)Marketed from Feb 10, 2022 | |
| 71335-2002-3 | 71335200203 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2002-3)Marketed from Feb 10, 2022 | |
| 71335-2002-4 | 71335200204 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2002-4)Marketed from Feb 10, 2022 | |
| 71335-2002-5 | 71335200205 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2002-5)Marketed from Feb 10, 2022 | |
| 71335-2002-6 | 71335200206 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2002-6)Marketed from Feb 10, 2022 | |
| 71335-2002-7 | 71335200207 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-2002-7)Marketed from Feb 10, 2022 | |
| 71335-2002-8 | 71335200208 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2002-8)Marketed from Feb 10, 2022 |
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)
- Eszopiclone
- Generic name (nonproprietary)
- eszopiclone
- Active ingredients
- Eszopiclone — 3 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oropharyngeal
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091166
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 71335-2002_971e13a2-156d-4423-9418-0f0acb05105aSPL ID 971e13a2-156d-4423-9418-0f0acb05105aSPL set ID e04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0cRxCUI 485465UNII UZX80K71OE
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N471335200201followed by a unit qualifier and the quantityPackage 71335-2002-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets have been shown to decrease sleep latency and improve sleep maintenance ( 1 ).…
Excerpt only. Read the full label for complete information.
About NDC 71335-2002
- What is NDC 71335-2002?
- 71335-2002 is the product NDC for Eszopiclone, Eszopiclone 3 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 8 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?
- 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 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 091166
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 2 mg/1 | Tablet, Film coatedOral | St Mary's Medical Park Pharmacy | 60760-526 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOropharyngeal | NuCare Pharmaceuticals,Inc. | 68071-2403 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc. USA | 68462-382 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc. USA | 68462-383 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc. USA | 68462-384 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8387 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-581 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOropharyngeal | Proficient Rx LP | 71205-633 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0512 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0574 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-352 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-353 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-354 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0407 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-076 |