What is NDC 58602-833?

58602-833 is the product NDC for Guaifenesin and Pseudoephedrine HCl, Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 tablet, extended release, listed with the FDA by Aurohealth LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Guaifenesin, Pseudoephedrine hydrochloride.

Aurohealth LLC, NDC labeler code 58602. 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 58602-833

NDC codes

FDA NDC Directory

Product NDC (as listed)58602-833Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58602-0833Add 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
58602-833-12	5860208331258602083312	1 BLISTER PACK in 1 CARTON (58602-833-12) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 25, 2020
58602-833-17	5860208331758602083317	2 BLISTER PACK in 1 CARTON (58602-833-17) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 25, 2020

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 — 600 mg/1Pseudoephedrine hydrochloride — 60 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Aurohealth LLCNDC labeler code 58602
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213203
Marketing start: Mar 25, 2020
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 58602-833_436b7cb6-bc72-4b51-986e-22ad631ce0a2SPL ID 436b7cb6-bc72-4b51-986e-22ad631ce0a2SPL set ID 644dae51-7865-408c-a603-5eddffb90e53RxCUI 1305603UNII 495W7451VQ, 6V9V2RYJ8NUPC 0358602833121
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

N458602083312 followed by a unit qualifier and the quantity

Package 58602-0833-12. 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 Sep 3, 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 nasal congestion due to common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58602-833

What is NDC 58602-833?: 58602-833 is the product NDC for Guaifenesin and Pseudoephedrine HCl, Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 tablet, extended release, listed with the FDA by Aurohealth LLC. It has 2 package NDCs, 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?: Aurohealth LLC, NDC labeler code 58602. 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 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	Granules India Ltd	62207-828	62207-0828-71
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

All 15 Guaifenesin and Pseudoephedrine HCl NDCs

Other NDCs under ANDA 213203

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

FDA NDC Directory listings under ANDA 213203
Product	Strength	Form · route	Labeler	Product NDC
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	WALGREEN CO.	0363-0134
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	WALGREEN CO.	0363-9946
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	KROGER COMPANY	30142-137
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	Amerisource Bergen	46122-801
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	Aurohealth LLC	58602-834
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	Meijer	79481-1002