Over-the-counter drug · ANDA

Guaifenesin Extended-Release (Guaifenesin) NDC 68094-048

Guaifenesin 600 mg/1 · Tablet, Multilayer, Extended release · Oral · Precision Dose Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68094-048Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68094-0048Add 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 NDC11-digit (billing)PackageCopy
68094-048-61680940048616809400486110 BLISTER PACK in 1 CARTON (68094-048-61) / 10 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK (68094-048-59)Marketed from Mar 22, 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 Extended-Release
Generic name (nonproprietary)
guaifenesin
Active ingredients
Guaifenesin — 600 mg/1
Dosage form
Tablet, Multilayer, Extended release
Route
Oral
Labeler
Precision Dose Inc.NDC labeler code 68094
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078912
Marketing start
Listing expires
Other FDA classes
Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 68094-048_9147ee25-d849-468c-a83d-7b413539c487SPL ID 9147ee25-d849-468c-a83d-7b413539c487SPL set ID 608b00c5-a2c7-4514-9b46-02954d6675d6RxCUI 636522UNII 495W7451VQUPC 0368094048613
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

N468094004861 followed by a unit qualifier and the quantity

Package 68094-0048-61. 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 .

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 68094-048

What is NDC 68094-048?
68094-048 is the product NDC for Guaifenesin Extended-Release (guaifenesin), Guaifenesin 600 mg/1 tablet, multilayer, extended release, listed with the FDA by Precision Dose Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Guaifenesin Extended-Release (Guaifenesin).
What is the active ingredient?
Guaifenesin.
Who is the labeler?
Precision Dose Inc., NDC labeler code 68094. 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 Extended-Release?
3 other product NDCs are listed under this name. See all Guaifenesin Extended-Release 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 Extended-Release NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Guaifenesin Extended ReleaseguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralKroger Company30142-96230142-0962-14
Guaifenesin Extended ReleaseguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralSAM'S WEST INC68196-99668196-0996-56
Guaifenesin Extended ReleaseguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralPUBLIX SUPER MARKETS, INC41415-99741415-0997-14

Other NDCs under ANDA 078912

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

FDA NDC Directory listings under ANDA 078912
ProductStrengthForm · routeLabelerProduct NDC
basic care mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralAmazon.com Services LLC72288-298
basic care mucus er maxguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralAmazon.com Services LLC72288-613
DG Health Mucus ERguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralDolgencorp, LLC55910-904
DG health mucus er maxguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralDolgencorp Inc55910-887
equate mucus reliefguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralWALMART INC.79903-327
equate mucus-erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralWALMART INC.79903-292
foster and thrive mucus reliefguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralStrategic Sourcing Services LLC70677-1291
Good Neighbor Pharmacy Mucus ERguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralAmerisource Bergen46122-814
good sense mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralL. Perrigo Company0113-2023
Good Sense Mucus ERguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralL. Perrigo Company0113-4077
good sense mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralRedpharm Drug67296-2223
Leader Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0721
Leader Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0758
mucusguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralCVS Pharmacy69842-806
Mucus And Chest CongestionguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-299
Mucus And Chest CongestionguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-520
mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralHyVee Inc42507-202
mucus erguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralHyVee Inc42507-471
mucus extended releaseguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-400
mucus reliefguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralMeijer Distribution Inc41250-684

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