What is NDC 53329-643?

53329-643 is the product NDC for Acetaminophen, Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Medline Industries, LP. It has 1 package NDC, shown above in 10- and 11-digit form.

Medline Industries, LP, NDC labeler code 53329. 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?

228 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Acetaminophen NDC 53329-643 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53329-643Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53329-0643Add 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 NDC	11-digit (billing)	Package	Copy
53329-643-29	53329064329	50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53329-643-29)Marketed from Jul 10, 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): Acetaminophen
Generic name (nonproprietary): acetaminophen
Active ingredients: Acetaminophen — 650 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Medline Industries, LPNDC labeler code 53329
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076200
Marketing start: Apr 30, 2002
Marketing end: Dec 31, 2026
Identifiers: Product ID 53329-643_4f1bbf5a-3e39-3618-e063-6394a90ac6c8SPL ID 4f1bbf5a-3e39-3618-e063-6394a90ac6c8SPL set ID 9f18d455-55ce-482c-8da8-dcb664038c6cRxCUI 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

N453329064329 followed by a unit qualifier and the quantity

Package 53329-0643-29. 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 Apr 10, 2026.

Indications (excerpt from the label)

Uses 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53329-643

What is NDC 53329-643?: 53329-643 is the product NDC for Acetaminophen, Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Medline Industries, LP. It has 1 package NDC, 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?: Medline Industries, LP, NDC labeler code 53329. 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?: 228 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
acetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Amazon.com Services LLC	72288-150	72288-0150-79
Acetaminophen	Acetaminophen 10 mg/mL	Injection, SolutionIntravenous	Somerset Therapeutics, LLC	70069-871	70069-0871-10
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Walgreens	0363-9810	00363-9810-1000363-9810-2500363-9810-50+1 more
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	PUBLIX SUPERMARKETS, INC	41415-175	41415-0175-0541415-0175-10
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Family Dollar, Inc.	55319-751	55319-0751-24
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Meijer Distribution Inc	79481-0780	79481-0780-0179481-0780-0279481-0780-04
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4132	68788-4132-0168788-4132-0268788-4132-03+1 more
acetaminophen	Acetaminophen 500 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-008	87441-0008-01
Acetaminophen	Acetaminophen 160 mg/5mL	SolutionOral	Acetris Pharma Holdings, LLC	52343-555	52343-0555-12
Acetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	Granules India Limited	62207-892	62207-0892-4962207-0892-51

All 229 Acetaminophen NDCs