Over-the-counter drug · OTC MONOGRAPH FINAL
Low Dose Aspirin Enteric Safety Coated (Aspirin) NDC 49483-381
Aspirin 81 mg/1 · Tablet, Delayed release · Oral · Time-Cap Labs, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-381-10 | 4948303811049483038110 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-381-10)Marketed from Dec 17, 2018 | |
| 49483-381-12 | 4948303811249483038112 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-381-12)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)
- Low Dose Aspirin Enteric Safety CoatedSuffix: Enteric Safety Coated
- Generic name (nonproprietary)
- aspirin
- Active ingredients
- Aspirin — 81 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Time-Cap Labs, IncNDC labeler code 49483
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part343
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 49483-381_7d3eb3e0-2eaa-1536-e053-2a91aa0a228bSPL ID 7d3eb3e0-2eaa-1536-e053-2a91aa0a228bSPL set ID 9cb0c2df-5e72-42c5-ae93-144201fd263cRxCUI 308416UNII R16CO5Y76EUPC 0349483381108
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
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
N449483038110followed by a unit qualifier and the quantityPackage 49483-0381-10. 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 for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
Excerpt only. Read the full label for complete information.
About NDC 49483-381
- What is NDC 49483-381?
- 49483-381 is the product NDC for Low Dose Aspirin Enteric Safety Coated, Aspirin 81 mg/1 tablet, delayed release, listed with the FDA by Time-Cap Labs, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Low Dose Aspirin Enteric Safety Coated (Aspirin).
- What is the active ingredient?
- Aspirin.
- Who is the labeler?
- Time-Cap Labs, 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 Low Dose Aspirin Enteric Safety Coated?
- 1 other product NDC are listed under this name. See all Low Dose Aspirin Enteric Safety Coated NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Low Dose Aspirin Enteric Safety Coated products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Low Dose Aspirin Enteric Safety Coatedaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Time-Cap Labs, Inc | 49483-328 | 49483-0328-0149483-0328-10 |
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 | Advance Pharmaceutical Inc. | 17714-011 |
| Broncochem Expectorant IIacetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl | Acetaminophen 250 mg/10mL + 4 more ingredients | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-116 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-010 |
| 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 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | PuraCap Pharmaceutical LLC | 51013-320 |
| Aspirin | Aspirin 81 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-121 |
| Doans Extra Strengthmagnesium salicylate | Magnesium salicylate 580 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 55741-224 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | CVS PHARMACY, INC. | 69842-390 |
| Chewable Acetaminophen Childrensacetaminophen | Acetaminophen 80 mg/1 | Tablet, ChewableOral | Richmond Pharmaceuticals, Inc. | 54738-092 |
| Childrens Tukol Acetaminophen Fever Reducer Pain Reduceracetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | Genomma Lab USA, Inc. | 50066-525 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-040 |
| Acetaminophen Diphenhydramine HCl | Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1 | TabletOral | Chain Drug Consortium,LLC | 68016-654 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc | 54738-111 |
| 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 | Acetaminophen 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-548 |
| Aspirin | Aspirin 81 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-559 |
Showing 20 of 37.