Over-the-counter drug · ANDA

Acetaminophen (Acetaminophen tablet extended release) NDC 71335-9746

Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-9746Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-9746Add 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
71335-9746-17133597460130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-1)Marketed from Nov 16, 2023
71335-9746-271335974602100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-2)Marketed from Apr 5, 2024
71335-9746-37133597460350 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-3)Marketed from Apr 5, 2024
71335-9746-47133597460460 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-4)Marketed from Apr 5, 2024
71335-9746-571335974605120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-5)Marketed from Apr 5, 2024
71335-9746-67133597460619 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-6)Marketed from Apr 5, 2024
71335-9746-77133597460720 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-7)Marketed from Apr 5, 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)
Acetaminophen
Generic name (nonproprietary)
acetaminophen tablet extended release
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215486
Marketing start
Listing expires
Identifiers
Product ID 71335-9746_61ea1796-b9c7-4cb9-9a36-60943f884875SPL ID 61ea1796-b9c7-4cb9-9a36-60943f884875SPL set ID 61ea1796-b9c7-4cb9-9a36-60943f884875RxCUI 1148399UNII 362O9ITL9D

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

N471335974601 followed by a unit qualifier and the quantity

Package 71335-9746-01. 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 For Arthritis Pain temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever For Muscle Aches & Pains temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-9746

What is NDC 71335-9746?
71335-9746 is the product NDC for Acetaminophen (acetaminophen tablet extended release), Acetaminophen 650 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?
Acetaminophen (Acetaminophen tablet extended release).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acetaminophen?
230 other product NDCs are listed under this name. See all Acetaminophen 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 Acetaminophen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
acetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmazon.com Services LLC72288-15072288-0150-79
AcetaminophenAcetaminophen 10 mg/mLInjection, SolutionIntravenousSomerset Therapeutics, LLC70069-87170069-0871-10
AcetaminophenAcetaminophen 500 mg/1TabletOralWalgreens0363-981000363-9810-1000363-9810-2500363-9810-50+1 more
AcetaminophenAcetaminophen 500 mg/1TabletOralFamily Dollar, Inc.55319-75155319-0751-24
AcetaminophenAcetaminophen 500 mg/1TabletOralPUBLIX SUPERMARKETS, INC41415-17541415-0175-0541415-0175-10
AcetaminophenAcetaminophen 500 mg/1TabletOralMeijer Distribution Inc79481-078079481-0780-0179481-0780-0279481-0780-04
AcetaminophenAcetaminophen 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-413268788-4132-0168788-4132-0268788-4132-03+1 more
acetaminophenAcetaminophen 500 mg/1TabletOralUnit Dose Solutions, Inc.87441-00887441-0008-01
AcetaminophenAcetaminophen 160 mg/5mLSolutionOralAcetris Pharma Holdings, LLC52343-55552343-0555-12
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules India Limited62207-89262207-0892-4962207-0892-51

All 231 Acetaminophen NDCs

Other NDCs under ANDA 215486

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

FDA NDC Directory listings under ANDA 215486
ProductStrengthForm · routeLabelerProduct NDC
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralKROGER COMPANY41226-704
8 hr Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDOLGENCORP, INC.55910-892
8 Hr Muscle Aches And PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCVS Pharmacy51316-354
8 hr Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDOLGENCORP, INC.55910-895
8hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMajor Pharmaceuticals0904-7561
8HR Arthritis Pain Reliefacetaminophen 650mgAcetaminophen 650 mg/1Tablet, Extended releaseOralCVS Pharmacy51316-969
8HR Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralLEADER/ Cardinal Health 110, Inc.70000-0733
8HR Muscle Aches and Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralLEADER/ Cardinal Health 110, Inc.70000-0734
8HR Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralTARGET CORPORATION11673-928
Acetaminophenacetaminophen tablet extended releaseAcetaminophen 650 mg/1Tablet, Extended releaseOralTIME CAP LABORATORIES, INC.49483-699
Acetaminophenacetaminophen tablet extended releaseAcetaminophen 650 mg/1Tablet, Extended releaseOralAsclemed USA, Inc.76420-914
Acetaminophen Extended-Release Tablets, 650 mgacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARKSANS PHARMA LIMITED25000-071
Acetaminophen Extended-Release Tablets, 650 mgacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARKSANS PHARMA LIMITED25000-108
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBETTER LIVING BRANDS, LLC21130-097
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralSAM'S WEST INC68196-034
Arthritis Pain AcetaminophenacetaminophenAcetaminophen 650 mg/1TabletOralTARGET CORPORATION11673-673
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralKROGER COMPANY41226-699
Arthritis Pain RelieveracetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralWALGREENS0363-9781
Muscle Aches and Pains Acetaminophen extended releaseacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralTIME CAP LABORATORIES, INC.49483-704

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