Over-the-counter drug · ANDA
eight hour pain relief (Acetaminophen) NDC 41163-203
Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · United Natural Foods, Inc. dba UNFI
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41163-203-02 | 4116302030241163020302 | 1 BOTTLE, PLASTIC in 1 CARTON (41163-203-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Apr 29, 2022 | |
| 41163-203-03 | 4116302030341163020303 | 1 BOTTLE, PLASTIC in 1 CARTON (41163-203-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Aug 1, 2022 |
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)
- eight hour pain relief
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 650 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- United Natural Foods, Inc. dba UNFINDC labeler code 41163
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
- Marketing start
- Listing expires
- Identifiers
- Product ID 41163-203_fbe58138-8e22-c4d9-e053-6294a90a3bd0SPL ID fbe58138-8e22-c4d9-e053-6294a90a3bd0SPL set ID b5fe8873-13c9-402e-b06c-6e679af7267eRxCUI 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
N441163020302followed by a unit qualifier and the quantityPackage 41163-0203-02. 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: 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.
About NDC 41163-203
- What is NDC 41163-203?
- 41163-203 is the product NDC for eight hour pain relief (acetaminophen), Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by United Natural Foods, Inc. dba UNFI. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- eight hour pain relief (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- United Natural Foods, Inc. dba UNFI, NDC labeler code 41163. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for eight hour pain relief?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 211544
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | WAL-MART STORES INC | 79903-137 |
| Tylenol 8 Hr Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Kenvue Brands LLC | 50580-575 |
| Tylenol 8 Hr Muscle Aches And Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Kenvue Brands LLC | 50580-576 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | AMERIFOODS TRADING COMPANY | 61504-200 |
| Arthritis Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | WINCO FOODS, LLC | 67091-401 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-660 |
| 8 Hour Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | MARC GLASSMAN, INC. | 68998-401 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | DISCOUNT DRUG MART | 53943-200 |
| 8 Hour Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-679 |
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | FAMILY DOLLAR | 55319-185 |
| 8HR Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | HARRIS TEETER | 72036-200 |
| Acetaminophen Extended-Releaseacetaminophen | Acetaminophen 650 mg/1 | TabletOral | Magno-Humphries, Inc. | 54257-573 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | RITE AID | 11822-5019 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | RITE AID | 11822-5019 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | GERI-CARE PHARMACEUTICAL CORP | 57896-268 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | RITE AID | 11822-5091 |
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | MEIJER DISTRIBUTION INC | 79481-0183 |
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | MEIJER, INC. | 79481-0184 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Grocery Outlet, Inc. | 85828-200 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Bi-Mart | 37835-512 |
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