Over-the-counter drug · ANDA
Guaifenesin Extended Release 600 mg (Guaifenesin) NDC 49483-723
Guaifenesin 600 mg/1 · Tablet · Oral · TIME CAP LABORATORIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-723-50 | 4948307235049483072350 | 500 TABLET in 1 BOTTLE (49483-723-50)Marketed from Jan 8, 2024 |
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)
- Guaifenesin Extended Release 600 mg
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INC.NDC labeler code 49483
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217780
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 49483-723_10c427f2-f75b-9e93-e063-6294a90ab0efSPL ID 10c427f2-f75b-9e93-e063-6294a90ab0efSPL set ID 10c42869-7df0-3046-e063-6394a90aa679RxCUI 310621, 636522UNII 495W7451VQUPC 0349483724707, 0349483723502
- 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
N449483072350followed by a unit qualifier and the quantityPackage 49483-0723-50. 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)
INDICATIONS & USAGE SECTION 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.
About NDC 49483-723
- What is NDC 49483-723?
- 49483-723 is the product NDC for Guaifenesin Extended Release 600 mg, Guaifenesin 600 mg/1 tablet, listed with the FDA by TIME CAP LABORATORIES, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin Extended Release 600 mg (Guaifenesin).
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- TIME CAP LABORATORIES, INC., NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Guaifenesin Extended Release 600 mg?
- 2 other product NDCs are listed under this name. See all Guaifenesin Extended Release 600 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guaifenesin Extended Release 600 mg products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Guaifenesin Extended Release 600 mgguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Wal-Mart Stores, Inc. | 79903-271 | 79903-0271-40 |
| Guaifenesin Extended-Release 600 mgguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Guardian Drug Company | 53041-233 | 53041-0233-3053041-0233-3253041-0233-38 |
Other NDCs under ANDA 217780
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 1200 mg/1 | Tablet, Extended releaseOral | BJWC (Berkley & Jensen / BJ's) | 68391-724 |
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | SAM'S WEST INC | 68196-033 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Grocery Outlet, Inc. | 85828-723 |
| Mucus Relief ERguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories | 0536-1249 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 51316-724 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 41226-723 |
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 41226-724 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | LEADER/ Cardinal Health 110, Inc. | 70000-0730 |
| Guaifenesin Extended Release 1200 mgguaifenesin | Guaifenesin 1200 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-724 |
| Guaifenesin 600 mg | Guaifenesin 600 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-042 |
| Guaifenesin 1200 mg | Guaifenesin 1200 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-041 |