Over-the-counter drug · ANDA

8 Hour Pain Relief (Acetaminophen) NDC 46122-630

Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · AMERISOURCE BERGEN

NDC codes

FDA NDC Directory
Product NDC (as listed)46122-630Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46122-0630Add 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
46122-630-71461220630711 BOTTLE, PLASTIC in 1 PACKAGE (46122-630-71) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Aug 27, 2024
46122-630-78461220630781 BOTTLE, PLASTIC in 1 CARTON (46122-630-78) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Jan 13, 2020

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)
8 Hour Pain Relief
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
AMERISOURCE BERGENNDC labeler code 46122
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
Marketing start
Listing expires
Identifiers
Product ID 46122-630_1e004cc6-5802-1e62-e063-6294a90aa220SPL ID 1e004cc6-5802-1e62-e063-6294a90aa220SPL set ID 9ab903aa-7170-460b-9527-e3df223f5f55RxCUI 1148399UNII 362O9ITL9DUPC 0087701432484

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

N446122063071 followed by a unit qualifier and the quantity

Package 46122-0630-71. 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 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 46122-630

What is NDC 46122-630?
46122-630 is the product NDC for 8 Hour Pain Relief (acetaminophen), Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by AMERISOURCE BERGEN. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
8 Hour Pain Relief (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
AMERISOURCE BERGEN, NDC labeler code 46122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for 8 Hour Pain Relief?
5 other product NDCs are listed under this name. See all 8 Hour Pain Relief 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 8 Hour Pain Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-08283324-0082-50
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralKROGER COMPANY41226-70441226-0704-01
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC70677-112370677-1123-01
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-67963868-0679-50
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralVALU MERCHANDISERS COMPANY63941-40163941-0401-02

Other NDCs under ANDA 211544

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

FDA NDC Directory listings under ANDA 211544
ProductStrengthForm · routeLabelerProduct NDC
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-629
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralVALU MERCHANDISERS COMPANY63941-300
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARC GLASSMAN, INC.68998-401
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-083
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-679
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralVALU MERCHANDISERS COMPANY63941-401
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC70677-1123
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-082
8 HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDr. Reddy's Laboratories Inc.75907-430
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralHARRIS TEETER72036-200
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralFSA STORE INC.81522-200
8HR Muscle Aches and PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAAA Pharmaceutical, Inc.57344-201
8HR Muscle Aches and PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralFSA STORE INC.81522-201
AcetaminophenAcetaminophen 650 mg/1TabletOralWalgreens0363-0892
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALGREENS0363-9992
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALGREENS CO.0363-9993
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8624
AcetaminophenAcetaminophen 650 mg/1TabletOralMAJOR PHARMACEUTICALS0904-7314
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-5019
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-5091

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