What is NDC 69168-461?

69168-461 is the product NDC for Pain Relief, Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by Allegiant Health. It has 3 package NDCs, shown above in 10- and 11-digit form.

Allegiant Health, NDC labeler code 69168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pain Relief?

64 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pain Relief NDC 69168-461 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69168-461Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69168-0461Add 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
69168-461-03	69168046103	250 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-461-03)Marketed from May 24, 2024
69168-461-17	69168046117	300 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-461-17)Marketed from Nov 18, 2024
69168-461-32	69168046132	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-461-32)Marketed from May 24, 2024

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): Pain Relief
Generic name (nonproprietary): pain relief
Active ingredients: Acetaminophen — 650 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Allegiant HealthNDC labeler code 69168
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
Marketing start: Apr 24, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 69168-461_597ef1fc-5ca5-4a06-958c-e2ddc6b6de84SPL ID 597ef1fc-5ca5-4a06-958c-e2ddc6b6de84SPL set ID f4720346-c3e0-4707-b007-1bf1f5e05707RxCUI 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

N469168046103 followed by a unit qualifier and the quantity

Package 69168-0461-03. 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 24, 2024.

Indications (excerpt from the label)

Use(s) • 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 69168-461

What is NDC 69168-461?: 69168-461 is the product NDC for Pain Relief, Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by Allegiant Health. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pain Relief.
What is the active ingredient?: Acetaminophen.
Who is the labeler?: Allegiant Health, NDC labeler code 69168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pain Relief?: 64 other product NDCs are listed under this name. See all 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 Pain Relief NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pain Reliefacetaminophen	Acetaminophen 325 mg/1	TabletOral	Shield Pharmaceuticals Corp.	83059-0160	—
Pain Reliefmenthol spray	Menthol 76.6 mg/mL	SprayTopical	Owell Naturals Brand, LLC	83570-003	83570-0003-02
Pain Reliefarnica montana, belladonna, gelsemium sempervirens, gnaphalium polycephalum, magnesia phosphorica, sanguinaria canadensis, salix alba	Arnica montana whole 6 [hp_X]/1 + 6 more ingredients	TabletOral	NaturalCare	70163-0022	70163-0022-01
pain reliefacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	HyVee Inc	42507-813	42507-0813-78
Pain Reliefmenthol	Menthol 10.5 g/100mL	SprayTopical	Trifecta Pharmaceuticals USA, LLC.	69396-175	69396-0175-03
Pain Reliefacetaminophen	Acetaminophen 500 mg/1	TabletOral	HYVEE INC	42507-103	42507-0103-04
Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	HYVEE INC	42507-303	42507-0303-03
Pain Reliefacetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	HYVEE INC	42507-404	42507-0404-09
Pain Reliefacetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	HYVEE INC	42507-592	42507-0592-03
Pain Relieflidocaine	Lidocaine .04 g/g	PatchTopical	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	73557-189	73557-0189-30

All 65 Pain Relief 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
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	WAL-MART STORES INC	49035-181
eight hour pain reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	United Natural Foods, Inc. dba UNFI	41163-203
Acetaminophen	Acetaminophen 650 mg/1	TabletOral	WAL-MART STORES INC	79903-137
Acetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	Bi-Mart	37835-512
Arthritis Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	TOPCO ASSOCIATES LLC	36800-632
Acetaminophen	Acetaminophen 650 mg/1	TabletOral	LEADER/ Cardinal Health 110, Inc	70000-0626
Acetaminophen	Acetaminophen 650 mg/1	TabletOral	LEADER/ Cardinal Health 110, Inc	70000-0627
8 Hour Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	STRATEGIC SOURCING SERVICES LLC	70677-1123
8HR Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	HARRIS TEETER	72036-200
Tylenol 8 Hr Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Kenvue Brands LLC	50580-575
Acetaminophen	Acetaminophen 650 mg/1	TabletOral	MEIJER DISTRIBUTION INC	79481-0183
Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	Grocery Outlet, Inc.	85828-200
Tylenol 8 Hr Muscle Aches And Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Kenvue Brands LLC	50580-576
8 Hour Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	VALU MERCHANDISERS COMPANY	63941-300
Acetaminophen	Acetaminophen 650 mg/1	TabletOral	MEIJER, INC.	79481-0184
Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	AMERIFOODS TRADING COMPANY	61504-200
Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	DISCOUNT DRUG MART	53943-200
Arthritis Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	WINCO FOODS, LLC	67091-401
Acetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Granules USA, Inc.	69848-015
Acetaminophen	Acetaminophen 650 mg/1	TabletOral	FAMILY DOLLAR	55319-185

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