What is NDC 71309-461?

71309-461 is the product NDC for Guaifenesin, Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Safrel Pharmaceuticals, LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.

Safrel Pharmaceuticals, LLC., NDC labeler code 71309. 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?

62 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Guaifenesin NDC 71309-461 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71309-461Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71309-0461Add 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
71309-461-56	71309046156	56 TABLET, EXTENDED RELEASE in 1 BOTTLE (71309-461-56)Marketed from Jun 29, 2022

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
Generic name (nonproprietary): guaifenesin
Active ingredients: Guaifenesin — 1200 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Safrel Pharmaceuticals, LLC.NDC labeler code 71309
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213420
Marketing start: Dec 18, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers: Product ID 71309-461_f7f18eb7-a4bc-b7f6-e053-6394a90a0f74SPL ID f7f18eb7-a4bc-b7f6-e053-6394a90a0f74SPL set ID e2a3d6cb-5251-b88e-e053-2a95a90a9e30RxCUI 310621UNII 495W7451VQUPC 0371309461565
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

N471309046156 followed by a unit qualifier and the quantity

Package 71309-0461-56. 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 Mar 28, 2023.

Indications (excerpt from the label)

USE(S) 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 71309-461

What is NDC 71309-461?: 71309-461 is the product NDC for Guaifenesin, Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Safrel Pharmaceuticals, LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Guaifenesin.
What is the active ingredient?: Guaifenesin.
Who is the labeler?: Safrel Pharmaceuticals, LLC., NDC labeler code 71309. 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?: 62 other product NDCs are listed under this name. See all Guaifenesin NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Guaifenesin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Guaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Aurohealth LLC	58602-857	58602-0857-93
Guaifenesinguaifenesin 400 mg	Guaifenesin 200 mg/1	TabletOral	Zennova LLC	81993-002	81993-0002-0181993-0002-0281993-0002-03+2 more
Guaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	TOPCO ASSOCIATES LLC	76162-031	76162-0031-56
Guaifenesin	Guaifenesin 600 mg/1	TabletOral	YYBA CORP	73581-400	73581-0400-0273581-0400-07
Guaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Sam's West Inc	68196-960	68196-0960-56
Guaifenesin	Guaifenesin 100 mg/5mL	LiquidOral	KESIN PHARMA CORPORATION	81033-102	81033-0102-16
Guaifenesin	Guaifenesin 100 mg/5mL	SolutionOral	American Health Packaging	60687-852	60687-0852-17
Guaifenesin	Guaifenesin 200 mg/10mL	SolutionOral	American Health Packaging	60687-863	60687-0863-56
Guaifenesin	Guaifenesin 300 mg/15mL	SolutionOral	American Health Packaging	60687-874	60687-0874-16
Guaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	GRANULES USA, INC.	69848-018	69848-0018-16

All 63 Guaifenesin NDCs

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 Relief	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Allegiant Health	69168-459
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 600 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	82804-265
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
Dr. Simi Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Farmacias De Similares TX LLC	85786-302
dg health mucus er maxguaifenesin	Guaifenesin 1200 mg/1	Tablet, Multilayer, Extended releaseOral	Dolgencorp Inc	55910-626
Curist Mucus Relief Maximum Strengthguaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Little Pharma, Inc.	72559-013
Curist Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Little Pharma, Inc.	72559-017
Guaifenesin	Guaifenesin 600 mg/1	TabletOral	Walgreens	0363-9569
Mucus Relief Maximum Strengthguaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	HARRIS TEETER	72036-204
Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	HARRIS TEETER	72036-203
Guaifenesin - Odaat 1200 Mgguaifenesin	Guaifenesin 1200 mg/1	TabletOral	LODAAT LLC	83139-175
Mucus Reliefguaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	AMERIFOODS TRADING COMPANY	61504-204
Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	NUVICARE LLC	84324-026
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mgguaifenesin	Guaifenesin 600 mg/1	TabletOral	TWIN MED LLC	55681-301
Mucus Relief Maximum Strengthguaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	WINCO FOODS, LLC	67091-404
Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	WINCO FOODS, LLC	67091-403
Guaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	GRANULES USA, INC.	69848-017

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