What is NDC 51316-009?

51316-009 is the product NDC for Guaifenesin and Dextromethorphan HBR, Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 tablet, extended release, listed with the FDA by CVS Pharmacy. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Guaifenesin, Dextromethorphan hydrobromide.

CVS Pharmacy, NDC labeler code 51316. 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 and Dextromethorphan HBR?

26 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Guaifenesin and Dextromethorphan HBR NDC 51316-009

NDC codes

FDA NDC Directory

Product NDC (as listed)51316-009Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51316-0009Add 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
51316-009-01	5131600090151316000901	5 BLISTER PACK in 1 CARTON (51316-009-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 15, 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): Guaifenesin and Dextromethorphan HBR
Generic name (nonproprietary): guaifenesin and dextromethorphan hbr
Active ingredients: Guaifenesin — 600 mg/1Dextromethorphan hydrobromide — 30 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: CVS PharmacyNDC labeler code 51316
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217340
Marketing start: Aug 15, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 51316-009_2885f0f5-e5ad-b667-c442-753a48d3f900SPL ID 2885f0f5-e5ad-b667-c442-753a48d3f900SPL set ID 7942eeae-0528-4416-bd2f-b05acc71c0a9RxCUI 1298324UNII 495W7451VQ, 9D2RTI9KYH
Pharmacologic class: Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist

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

N451316000901 followed by a unit qualifier and the quantity

Package 51316-0009-01. 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 Nov 10, 2024.

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 temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51316-009

What is NDC 51316-009?: 51316-009 is the product NDC for Guaifenesin and Dextromethorphan HBR, Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 tablet, extended release, listed with the FDA by CVS Pharmacy. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Guaifenesin and Dextromethorphan HBR.
What is the active ingredient?: Guaifenesin, Dextromethorphan hydrobromide.
Who is the labeler?: CVS Pharmacy, NDC labeler code 51316. 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 and Dextromethorphan HBR?: 26 other product NDCs are listed under this name. See all Guaifenesin and Dextromethorphan HBR 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 and Dextromethorphan HBR NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Guaifenesin And Dextromethorphan HBr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	TOPCO ASSOCIATES LLC	76162-032	76162-0032-56
Guaifenesin and Dextromethorphan HBr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Target Corporation	11673-267	11673-0267-0511673-0267-5711673-0267-60
Guaifenesin and Dextromethorphan HBr	Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1	Tablet, Extended releaseOral	KROGER COMPANY	30142-276	30142-0276-2030142-0276-40
Guaifenesin and Dextromethorphan HBr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	KROGER COMPANY	30142-275	30142-0275-0530142-0275-14
Guaifenesin and Dextromethorphan HBR	Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Inc.	43598-114	43598-0114-0143598-0114-2043598-0114-40
Guaifenesin and Dextromethorphan HBR	Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Inc.	43598-231	43598-0231-01
Guaifenesin and Dextromethorphan HBR	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Inc.	43598-232	43598-0232-37
Guaifenesin and Dextromethorphan HBr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	VESPYR BRANDS LLC	71179-011	71179-0011-21
Guaifenesin And Dextromethorphan HBr	Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1	Tablet, Extended releaseOral	Kroger Company	30142-948	30142-0948-2030142-0948-40
Guaifenesin And Dextromethorphan HBr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Kroger Company	30142-963	30142-0963-1430142-0963-28

All 27 Guaifenesin and Dextromethorphan HBR NDCs

Other NDCs under ANDA 217340

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

FDA NDC Directory listings under ANDA 217340
Product	Strength	Form · route	Labeler	Product NDC
Guaifenesin and Dextromethorphan HBR	Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Inc.	43598-114
Guaifenesin and Dextromethorphan HBR	Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Inc.	43598-231
Guaifenesin and Dextromethorphan HBR	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Inc.	43598-232
Members Mark Mucus Relief DMguaifenesin and dextromethorphan hbr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	SAM'S WEST INC	68196-999