What is NDC 68391-000?

68391-000 is the product NDC for berkley and jensen mucus relief (guaifenesin), Guaifenesin 1200 mg/1 tablet, multilayer, extended release, listed with the FDA by BJWC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

berkley and jensen mucus relief (Guaifenesin).

BJWC, NDC labeler code 68391. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for berkley and jensen mucus relief?

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.

berkley and jensen mucus relief NDC 68391-000

NDC codes

FDA NDC Directory

Product NDC (as listed)68391-000Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68391-0000Add 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
68391-000-45	68391000045	4 BLISTER PACK in 1 CARTON (68391-000-45) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 4, 2021

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): berkley and jensen mucus relief
Generic name (nonproprietary): guaifenesin
Active ingredients: Guaifenesin — 1200 mg/1
Dosage form: Tablet, Multilayer, Extended release
Route: Oral
Labeler: BJWCNDC labeler code 68391
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213420
Marketing start: Apr 4, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers: Product ID 68391-000_6792a293-6488-4eb4-adb6-0d8dbe93d4fcSPL ID 6792a293-6488-4eb4-adb6-0d8dbe93d4fcSPL set ID 433588eb-18ad-473f-9527-4947a143824eRxCUI 310621UNII 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

N468391000045 followed by a unit qualifier and the quantity

Package 68391-0000-45. 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 19, 2022.

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 68391-000

What is NDC 68391-000?: 68391-000 is the product NDC for berkley and jensen mucus relief (guaifenesin), Guaifenesin 1200 mg/1 tablet, multilayer, extended release, listed with the FDA by BJWC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: berkley and jensen mucus relief (Guaifenesin).
What is the active ingredient?: Guaifenesin.
Who is the labeler?: BJWC, NDC labeler code 68391. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for berkley and jensen mucus relief?: 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
12 Hour Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	CHAIN DRUG MARKETING ASSOCIATION INC	63868-149
basic care mucus er maxguaifenesin	Guaifenesin 1200 mg/1	Tablet, Multilayer, Extended releaseOral	Amazon.com Services LLC	72288-650
Betr chest congestion reliefguaifenesin	Guaifenesin 1200 mg/1	Tablet, Multilayer, Extended releaseOral	Live Betr LLC	80267-002
Betr remedies chest congestion reliefguaifenesin	Guaifenesin 1200 mg/1	Tablet, Multilayer, Extended releaseOral	Live Betr LLC	80267-010
Crcle Guaifenesin Extended-Release Tablets, 600 mgguaifenesin extended-release	Guaifenesin 600 mg/1	TabletOral	Innovus Pharmaceuticals, Inc.	57483-270
Crcle Guaifensin Extended Release Tablet, 1200 mgguaifensin extended-release	Guaifenesin 1200 mg/1	TabletOral	Innovus Pharmaceuticals, Inc.	57483-280
Curist Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Little Pharma, Inc.	72559-017
Curist Mucus Relief Maximum Strengthguaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Little Pharma, Inc.	72559-013
dg health mucus er maxguaifenesin	Guaifenesin 1200 mg/1	Tablet, Multilayer, Extended releaseOral	Dolgencorp Inc	55910-626
Dr. Simi Mucus Reliefguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Farmacias De Similares TX LLC	85786-302
Expectorant Guaifenesin Extended-Releaseguaifenesin	Guaifenesin 1200 mg/1	TabletOral	YET HEALTH GROUP LLC	81179-007
Good Sense Mucus ERguaifenesin	Guaifenesin 1200 mg/1	Tablet, Multilayer, Extended releaseOral	L. Perrigo Company	0113-3650
Guaifenesin	Guaifenesin 1200 mg/1	TabletOral	Walgreens	0363-0570
Guaifenesin	Guaifenesin 600 mg/1	TabletOral	Walgreens	0363-9569
Guaifenesin	Guaifenesin 600 mg/1	TabletOral	TARGET CORPORATION	11673-539
Guaifenesin	Guaifenesin 1200 mg/1	TabletOral	TARGET CORPORATION	11673-840
Guaifenesin	Guaifenesin 1200 mg/1	TabletOral	Safeway, Inc	21130-554
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
Guaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Granules India Ltd	62207-839

Showing 20 of 39.

berkley and jensen mucus relief (Guaifenesin) NDC 68391-000