Over-the-counter drug · ANDA
Crcle Guaifenesin Extended-Release Tablets, 600 mg NDC 57483-270
guaifenesin extended-release · Guaifenesin 600 mg/1 · Tablet · Oral · Innovus Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57483-270-01 | 57483027001 | 5 BLISTER PACK in 1 CARTON (57483-270-01) / 20 TABLET in 1 BLISTER PACKMarketed from Apr 28, 2023 |
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)
- Crcle Guaifenesin Extended-Release Tablets, 600 mg
- Generic name (nonproprietary)
- guaifenesin extended-release
- Active ingredients
- Guaifenesin — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213420
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 57483-270_77d8fc95-d94b-42f5-97ae-b5ff59ef638bSPL ID 77d8fc95-d94b-42f5-97ae-b5ff59ef638bSPL set ID bba4b91a-bea9-41be-9588-5fb1483c7d10RxCUI 310621, 636522UNII 495W7451VQ
- Pharmacologic class
- Expectorant
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
N457483027001followed by a unit qualifier and the quantityPackage 57483-0270-01. 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)
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213420
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 |
|---|---|---|---|---|
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | AAA Pharmaceutical, Inc. | 57344-203 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Pioneer Life Sciences, LLC | 72090-011 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Pioneer Life Sciences, LLC | 72090-012 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Advanced Rx LLC | 80513-403 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Advanced Rx LLC | 80513-413 |
| basic care mucus er maxguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Multilayer, Extended releaseOral | Amazon.com Services LLC | 72288-650 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Demoulas Super Markets, Inc | 53942-203 |
| Mucus Relief Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Demoulas Super Markets, Inc | 53942-204 |
| Guaifenesin | Guaifenesin 1200 mg/1 | TabletOral | Safeway, Inc | 21130-554 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Granules India Ltd | 62207-569 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | CVS PHARMACY, INC | 69842-335 |
| Good Sense Mucus ERguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Multilayer, Extended releaseOral | L. Perrigo Company | 0113-3650 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Granules India Ltd | 62207-570 |
| Crcle Guaifensin Extended Release Tablet, 1200 mgguaifensin extended-release | Guaifenesin 1200 mg/1 | TabletOral | Innovus Pharmaceuticals, Inc. | 57483-280 |
| Guaifenesin | Guaifenesin 1200 mg/1 | TabletOral | Walgreens | 0363-0570 |
| Betr chest congestion reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Multilayer, Extended releaseOral | Live Betr LLC | 80267-002 |
| Betr remedies chest congestion reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Multilayer, Extended releaseOral | Live Betr LLC | 80267-010 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Granules India Ltd | 62207-839 |
| Guaifenesin | Guaifenesin 1200 mg/1 | TabletOral | TARGET CORPORATION | 11673-840 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Granules India Ltd | 62207-840 |
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