Over-the-counter drug · OTC MONOGRAPH NOT FINAL
Acetaminophen NDC 49483-342
Acetaminophen 500 mg/1 · Tablet, Film coated · Oral · TIME CAP LABORATORIES, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-342-00 | 49483034200 | 100000 TABLET, FILM COATED in 1 CARTON (49483-342-00)Marketed from Dec 17, 2018 | |
| 49483-342-01 | 49483034201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-342-01)Marketed from Dec 17, 2018 | |
| 49483-342-10 | 49483034210 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-342-10)Marketed from Dec 17, 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 — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INCNDC labeler code 49483
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part343
- Marketing start
- Listing expires
- Identifiers
- Product ID 49483-342_7d3e2e18-1dee-4000-e053-2a91aa0aeefeSPL ID 7d3e2e18-1dee-4000-e053-2a91aa0aeefeSPL set ID 2569383a-4a05-4ddb-852e-b37e487ffcdeRxCUI 198440UNII 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
N449483034200followed by a unit qualifier and the quantityPackage 49483-0342-00. 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)
INDICATIONS AND USAGE: Pain Reliever – temporarily relieves minor aches and pains due to: the common cold, headache, backache, muscular aches, toothache, premenstrual and menstrual cramps, minor pain of arthritis. Temporarily reduces fever.
Excerpt only. Read the full label for complete information.
About NDC 49483-342
- What is NDC 49483-342?
- 49483-342 is the product NDC for Acetaminophen, Acetaminophen 500 mg/1 tablet, film coated, listed with the FDA by TIME CAP LABORATORIES, INC. It has 3 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?
- TIME CAP LABORATORIES, INC, NDC labeler code 49483. 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 part343
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 |
|---|---|---|---|---|
| Aspirin | Aspirin 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-541 |
| Aspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Richmond Pharmaceuticals, Inc. | 54738-128 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-540 |
| Acetaminophen Diphenhydramine HCl | Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1 | TabletOral | Chain Drug Consortium,LLC | 68016-654 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-548 |
| Aspirin | Aspirin 81 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-559 |
| Acetaminophen Capletsacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Breeden Brothers, LLC | 70729-001 |
| Acetaminophen Capletsacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Breeden Brothers, LLC | 70729-175 |
| Good Sense Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Preferred Pharmaceuticals Inc. | 68788-8646 |
| Pain Relief PMacetaminophen pm | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Velocity Pharma | 76168-119 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-238 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Velocity Pharma LLC | 76168-120 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-010 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-011 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-012 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-013 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-014 |
| Geritrex Aspirinaspirin | Aspirin 325 mg/1 | Tablet, CoatedOral | Geritrex LLC | 54162-940 |
| Childrens Tukol Acetaminophen Fever Reducer Pain Reduceracetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | Genomma Lab USA, Inc. | 50066-525 |
| Aspirin | Aspirin 81 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-121 |
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