What is NDC 62207-828?

62207-828 is the product NDC for Guaifenesin and Pseudoephedrine HCl, Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, extended release, listed with the FDA by Granules India Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Guaifenesin, Pseudoephedrine hydrochloride.

Granules India Ltd, NDC labeler code 62207. 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 Pseudoephedrine HCl?

14 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 Pseudoephedrine HCl NDC 62207-828

NDC codes

FDA NDC Directory

Product NDC (as listed)62207-828Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62207-0828Add 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
62207-828-71	6220708287162207082871	7 BLISTER PACK in 1 CARTON (62207-828-71) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 1, 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 Pseudoephedrine HCl
Generic name (nonproprietary): guaifenesin and pseudoephedrine hcl
Active ingredients: Guaifenesin — 1200 mg/1Pseudoephedrine hydrochloride — 120 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Granules India LtdNDC labeler code 62207
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216082
Marketing start: Jun 1, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers: Product ID 62207-828_5d3effb4-3018-8ca9-e063-6394a90ae6acSPL ID 5d3effb4-3018-8ca9-e063-6394a90ae6ac
Pharmacologic class: Expectorant; alpha-Adrenergic Agonist

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

N462207082871 followed by a unit qualifier and the quantity

Package 62207-0828-71. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 62207-828

What is NDC 62207-828?: 62207-828 is the product NDC for Guaifenesin and Pseudoephedrine HCl, Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, extended release, listed with the FDA by Granules India Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Guaifenesin and Pseudoephedrine HCl.
What is the active ingredient?: Guaifenesin, Pseudoephedrine hydrochloride.
Who is the labeler?: Granules India Ltd, NDC labeler code 62207. 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 Pseudoephedrine HCl?: 14 other product NDCs are listed under this name. See all Guaifenesin and Pseudoephedrine HCl 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 Pseudoephedrine HCl NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	Strategic Sourcing Services LLC	70677-1263	70677-1263-01
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	Amerisource Bergen	46122-801	46122-0801-08
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	Granules India Ltd	62207-827	62207-0827-72
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	WALGREEN CO.	0363-9946	00363-9946-4000363-9946-45
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	Rite Aid Corporation	11822-0046	11822-0046-0111822-0046-02
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	Meijer	79481-1002	79481-1002-01
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	KROGER COMPANY	30142-137	30142-0137-1230142-0137-17
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	Ohm Laboratories, Inc.	51660-074	51660-0074-18
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	Ohm Laboratories, Inc.	51660-077	51660-0077-12
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	WALGREEN CO.	0363-0134	00363-0134-78

All 15 Guaifenesin and Pseudoephedrine HCl NDCs

Other NDCs under ANDA 216082

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

FDA NDC Directory listings under ANDA 216082
Product	Strength	Form · route	Labeler	Product NDC
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	Granules India Ltd	62207-827