Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen NDC 0121-0941
Acetaminophen 160 mg/5mL · Suspension · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-0941-00 | 00121094100 | 10 TRAY in 1 CASE (0121-0941-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0941-05)Marketed from Sep 3, 2021 | |
| 0121-0941-94 | 00121094194 | 3 TRAY in 1 CASE (0121-0941-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0941-05)Marketed from Sep 3, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 160 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Identifiers
- Product ID 0121-0941_bbd6f65a-a6ec-4c17-935c-ed743c45e2c8SPL ID bbd6f65a-a6ec-4c17-935c-ed743c45e2c8SPL set ID caf5daea-409e-5dd2-e053-2995a90acb12RxCUI 307668UNII 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
N400121094100followed by a unit qualifier and the quantityPackage 00121-0941-00. 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: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Excerpt only. Read the full label for complete information.
About NDC 0121-0941
- What is NDC 0121-0941?
- 0121-0941 is the product NDC for Acetaminophen, Acetaminophen 160 mg/5mL suspension, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 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?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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.
Related NDCs: other Acetaminophen products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under M 013
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 and Diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | WALMART INC. | 79903-267 |
| Cabinet Pain Reliever and Fever Reducer Refill Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-3027 |
| Topcare Aspirinaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Topco Associates LLC | 36800-274 |
| CounterAct Painacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Melaleuca, Inc. | 54473-305 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Precision Dose, Inc. | 68094-042 |
| Aspirin Regular Strengthaspirin | Aspirin 325 mg/1 | Tablet, Delayed releaseOral | Rugby Laboratories | 0536-1232 |
| Childrens Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | AptaPharma Inc. | 76281-526 |
| Acetaminophen Regular Strengthacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Magno-Humphries, Inc. | 54257-720 |
| Duralgina Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Menper Distributors, Inc. | 53145-830 |
| Best Choice Effervescent Antacid Pain Reliefaspirin, citric acid, sodium bicarbonate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Valu Merchandisers Company | 63941-421 |
| Pain Relief Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | MARC GLASSMAN, INC. | 68998-392 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Precision Dose, Inc. | 68094-038 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Trifecta Pharmaceuticals USA LLC | 69396-144 |
| MAPAP Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-1987 |
| aspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Meijer Distribution Inc | 41250-467 |
| Aspirin | Aspirin 325 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6195 |
| Pain Reliever Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Wal-Mart Stores Inc | 49035-919 |
| Aspirin | Aspirin 325 mg/1 | Tablet, CoatedOral | TIME CAP LABS INC | 49483-011 |
| rapid release pain reliefacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Publix Super Markets Inc | 56062-650 |
| Back and Body Pain Reliefaspirin, caffeine | Aspirin 500 mg/1; Caffeine 32.5 mg/1 | Tablet, Film coatedOral | WinCo Foods, LLC | 67091-430 |
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