Prescription drug · ANDA
Eszopiclone NDC 70518-4398
Eszopiclone 2 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4398-0 | 70518439800 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4398-0)Marketed from Jul 24, 2025 |
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 — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202929
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 70518-4398_5b20f7a9-774a-bf90-e063-6294a90a480dSPL ID 5b20f7a9-774a-bf90-e063-6294a90a480dSPL set ID 9dfe774a-2c7a-4e10-bedd-cde64ad28676RxCUI 485442UNII 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 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
N470518439800followed by a unit qualifier and the quantityPackage 70518-4398-00. 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 has been shown to decrease sleep latency and improve sleep maintenance ( 1 )…
Excerpt only. Read the full label for complete information.
About NDC 70518-4398
- What is NDC 70518-4398?
- 70518-4398 is the product NDC for Eszopiclone, Eszopiclone 2 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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?
- 89 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. | 70518-4361 | 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 | Proficient Rx LP | 82804-159 | 82804-0159-3082804-0159-6082804-0159-90 |
| 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 | 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 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-348 | 69452-0348-20 |
Other NDCs under ANDA 202929
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 3 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3576 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0089 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-843 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0116 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-300 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0168 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-299 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-301 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-970 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7029 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Quality Care Products LLC | 55700-581 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Quality Care Products LLC | 55700-610 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-024 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7169 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-026 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-027 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8826 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | DIRECT RX | 61919-033 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0065 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0062 |
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