What is NDC 57483-270?

57483-270 is the product NDC for Crcle Guaifenesin Extended-Release Tablets, 600 mg, Guaifenesin 600 mg/1 tablet, listed with the FDA by Innovus Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Crcle Guaifenesin Extended-Release Tablets, 600 mg (Guaifenesin Extended-Release).

Innovus Pharmaceuticals, Inc., NDC labeler code 57483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Crcle Guaifenesin Extended-Release Tablets, 600 mg?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 57483-270

NDC codes

FDA NDC Directory

Product NDC (as listed)57483-270Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57483-0270Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
57483-270-01	5748302700157483027001	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
Labeler: Innovus Pharmaceuticals, Inc.NDC labeler code 57483
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213420
Marketing start: Sep 10, 2020
Listing expires: Dec 31, 2026
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

N457483027001 followed by a unit qualifier and the quantity

Package 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 Apr 8, 2023.

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.

Full label on DailyMed (opens in a new tab)

About NDC 57483-270

What is NDC 57483-270?: 57483-270 is the product NDC for Crcle Guaifenesin Extended-Release Tablets, 600 mg, Guaifenesin 600 mg/1 tablet, listed with the FDA by Innovus Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Crcle Guaifenesin Extended-Release Tablets, 600 mg (Guaifenesin Extended-Release).
What is the active ingredient?: Guaifenesin.
Who is the labeler?: Innovus Pharmaceuticals, Inc., NDC labeler code 57483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Crcle Guaifenesin Extended-Release Tablets, 600 mg?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 213420

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 213420
Product	Strength	Form · route	Labeler	Product NDC
Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	TabletOral	Bi-Mart	37835-408
Mucus Reliefguaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Bi-Mart	37835-412
Guaifenesin	Guaifenesin 1200 mg/1	TabletOral	Walgreens	0363-0570
Guaifenesin	Guaifenesin 600 mg/1	TabletOral	Walgreens	0363-9569
Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	AAA Pharmaceutical, Inc.	57344-203
Guaifenesin	Guaifenesin 1200 mg/1	TabletOral	SAM'S WEST INC	68196-405
Guaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	CVS PHARMACY, INC	69842-335
Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Advanced Rx LLC	80513-403
Good Sense Mucus ERguaifenesin	Guaifenesin 1200 mg/1	Tablet, Multilayer, Extended releaseOral	L. Perrigo Company	0113-3650
Guaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Advanced Rx LLC	80513-413
Guaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Granules India Ltd	62207-569
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
Mucus Reliefguaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	CHAIN DRUG MARKETING ASSOCIATION, INC.	83324-096
Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	CHAIN DRUG MARKETING ASSOCIATION, INC.	83324-097
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
Maximum Strength Mucus Reliefguaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	CHAIN DRUG MARKETING ASSOCIATION INC	63868-148
Guaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	GRANULES PHARMACEUTICALS INC.	70010-199
12 Hour Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	CHAIN DRUG MARKETING ASSOCIATION INC	63868-149

Showing 20 of 39.

Crcle Guaifenesin Extended-Release Tablets, 600 mg (Guaifenesin extended-release) NDC 57483-270