Over-the-counter drug · ANDA

Acetaminophen NDC 62207-183

Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · Granules India Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)62207-183Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62207-0183Add 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
62207-183-3462207018334622070183341 POUCH in 1 BOX (62207-183-34) / 5 TABLET, EXTENDED RELEASE in 1 POUCHMarketed from Jun 30, 2019
62207-183-3562207018335622070183356 POUCH in 1 BOX (62207-183-35) / 3000 TABLET, EXTENDED RELEASE in 1 POUCHMarketed from May 4, 2024
62207-183-4962207018349622070183491000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-183-49)Marketed from Apr 18, 2019
62207-183-5162207018351622070183511 BOTTLE in 1 CARTON (62207-183-51) / 10 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Apr 18, 2019
62207-183-8762207018387622070183871 POUCH in 1 BOX (62207-183-87) / 1 TABLET, EXTENDED RELEASE in 1 POUCHMarketed from Jun 30, 2019
62207-183-97622070183976220701839740000 TABLET, EXTENDED RELEASE in 1 DRUM (62207-183-97)Marketed from Mar 25, 2021

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)
Acetaminophen
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Granules India LimitedNDC labeler code 62207
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
Marketing start
Listing expires
Identifiers
Product ID 62207-183_5447f567-0cef-ae0a-e063-6394a90ad867SPL ID 5447f567-0cef-ae0a-e063-6394a90ad867SPL set ID 00eb3e4b-1507-4c9a-83a5-ef50cb312753RxCUI 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

N462207018334 followed by a unit qualifier and the quantity

Package 62207-0183-34. 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 label • 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 & Pain label • 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 62207-183

What is NDC 62207-183?
62207-183 is the product NDC for Acetaminophen, Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by Granules India Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Acetaminophen.
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Granules India Limited, NDC labeler code 62207. 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?
234 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 500 mg/1TabletOralREMEDYREPACK INC.70518-478770518-4787-00
AcetaminophenAcetaminophen 325 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478270518-4782-0070518-4782-01
AcetaminophenAcetaminophen 500 mg/1TabletOralREMEDYREPACK INC.70518-478370518-4783-00
AcetaminophenAcetaminophen 500 mg/1TabletOralAmazon.com Services LLC72288-44072288-0440-09
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/1TabletOralPUBLIX SUPERMARKETS, INC41415-17541415-0175-0541415-0175-10
AcetaminophenAcetaminophen 500 mg/1TabletOralFamily Dollar, Inc.55319-75155319-0751-24
AcetaminophenAcetaminophen 500 mg/1TabletOralMeijer Distribution Inc79481-078079481-0780-0179481-0780-0279481-0780-04

All 235 Acetaminophen NDCs

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
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGrocery Outlet, Inc.85828-200
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBi-Mart37835-512
AcetaminophenAcetaminophen 650 mg/1TabletOralWalgreens0363-0892
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralTOPCO ASSOCIATES LLC36800-632
8HR Muscle Aches and PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAAA Pharmaceutical, Inc.57344-201
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralCVS PHARMACY iNC69842-297
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAAA Pharmaceutical, Inc.57344-200
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralCVS PHARMACY INC69842-322
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules India Limited62207-188
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8624
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, INC.83324-082
AcetaminophenAcetaminophen 650 mg/1TabletOralSAM'S WEST INC68196-935
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules Pharmaceuticals Inc.70010-160
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-1340
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDemoulas Super Markets, Inc53942-200
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWAL-MART STORES INC49035-181
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALGREENS0363-9992
DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mgacetaminophenAcetaminophen 650 mg/1TabletOralBENARD INDUSTRIES INC55959-179
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules India Limited62207-892

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