Over-the-counter drug · NDA

Mucinex (Guaifenesin) NDC 63629-7115

Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-7115Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-7115Add 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
63629-7115-16362971150130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-1)Marketed from Apr 2, 2024
63629-7115-26362971150220 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-2)Marketed from Oct 17, 2016
63629-7115-36362971150360 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-3)Marketed from Apr 2, 2024
63629-7115-46362971150440 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-4)Marketed from Feb 4, 2019
63629-7115-56362971150514 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-5)Marketed from Apr 2, 2024
63629-7115-6636297115066 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-6)Marketed from Apr 2, 2024
63629-7115-76362971150710 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-7)Marketed from Apr 2, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Mucinex
Generic name (nonproprietary)
guaifenesin
Active ingredients
Guaifenesin — 600 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021282
Marketing start
Listing expires
Other FDA classes
Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 63629-7115_14931cd1-5c04-4801-aa6e-18138a21b28eSPL ID 14931cd1-5c04-4801-aa6e-18138a21b28eSPL set ID a898b584-e17e-45c4-8a28-9f686b95dca0RxCUI 636522, 891301UNII 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

N463629711501 followed by a unit qualifier and the quantity

Package 63629-7115-01. 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 .

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 63629-7115

What is NDC 63629-7115?
63629-7115 is the product NDC for Mucinex (guaifenesin), Guaifenesin 600 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mucinex (Guaifenesin).
What is the active ingredient?
Guaifenesin.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mucinex?
11 other product NDCs are listed under this name. See all Mucinex 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 Mucinex NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAmerican Health Packaging68084-57268084-0572-01
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralCardinal Health 107, LLC55154-468055154-4680-00
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralATLANTIC BIOLOGICAS CORP.17856-000817856-0008-02
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralReckitt Benckiser LLC63824-00863824-0008-1563824-0008-2763824-0008-32+9 more
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-134050090-1340-00
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-788663629-7886-0163629-7886-02
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC67544-14967544-0149-5367544-0149-7067544-0149-80
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralProficient Rx LP63187-95463187-0954-2063187-0954-40
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-081850090-0818-00
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-607850090-6078-00

All 12 Mucinex NDCs

Other NDCs under NDA 021282

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

FDA NDC Directory listings under NDA 021282
ProductStrengthForm · routeLabelerProduct NDC
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralProficient Rx LP63187-954
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC67544-149
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-0818
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAmerican Health Packaging68084-572
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-6078
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralCardinal Health 107, LLC55154-4680
Mucinex Maximum StrengthguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-2301
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-2380
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralATLANTIC BIOLOGICAS CORP.17856-0008
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralReckitt Benckiser LLC63824-008
Mucinex Maximum StrengthguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralReckitt Benckiser LLC63824-023
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-1340
MucinexguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-7886

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Mucinex NDC 63629-7115 | National Drug Code | Med-Code