Over-the-counter drug · ANDA

Guaifenesin NDC 65162-036

Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · Amneal Pharmaceuticals LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)65162-036Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65162-0036Add 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
65162-036-02651620036022 BLISTER PACK in 1 CARTON (65162-036-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 27, 2018
65162-036-03651620036031 BOTTLE in 1 CARTON (65162-036-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 27, 2018
65162-036-06651620036061 BOTTLE in 1 CARTON (65162-036-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 27, 2018

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
Generic name (nonproprietary)
guaifenesin
Active ingredients
Guaifenesin — 600 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207342
Marketing start
Listing expires
Other FDA classes
Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 65162-036_f1b3934b-1fc2-4ce8-9465-e1f031daf9c5SPL ID f1b3934b-1fc2-4ce8-9465-e1f031daf9c5SPL set ID ad67e6fd-a68f-44db-9718-84a2cef86e09RxCUI 310621, 636522UNII 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

N465162003602 followed by a unit qualifier and the quantity

Package 65162-0036-02. 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)

Other NDCs under ANDA 207342

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

FDA NDC Directory listings under ANDA 207342
ProductStrengthForm · routeLabelerProduct NDC
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralRite Aid Corporation11822-3252
Mucus Relief Extended Release Maximum StrengthguaifenesinGuaifenesin 1200 mg/1TabletOralCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-0479
Mucus Relief ERguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralMajor Pharmaceuticals0904-6718
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralH E B37808-935
Mucus Relief Extended ReleaseguaifenesinGuaifenesin 1200 mg/1TabletOralTARGET Corporation11673-732
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralStrategic Sourcing Services LLC70677-1052
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralStrategic Sourcing Services LLC70677-1051
Mucus Relief ERguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralCardinal Health 107, LLC55154-4153
Mucus Relief Maximum StrengthguaifenesinGuaifenesin 1200 mg/1TabletOralCare One (American Sales Company)41520-732
Mucus Relief Extended ReleaseguaifenesinGuaifenesin 600 mg/1TabletOralCare One (American Sales Company)41520-731
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralHarris Teeter, LLC69256-731
Mucus Relief Extended ReleaseguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralRugby Laboratories, Inc.0536-1163
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralWinCo Foods, LLC67091-370
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAmneal Pharmaceuticals LLC65162-037
Mucus Relief Extended Release Maximum StrengthguaifenesinGuaifenesin 1200 mg/1TabletOralWalgreens0363-0832
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-739
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralP & L Development, LLC59726-237
Mucus Relief Extended ReleaseguaifenesinGuaifenesin 600 mg/1TabletOralRedpharm Drug Inc.67296-1467
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralUnited Natural Foods, Inc. dba UNFI41163-731
Mucus Relief Extended Release Maximum StrengthguaifenesinGuaifenesin 1200 mg/1TabletOralH E B37808-762

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