Over-the-counter drug · OTC MONOGRAPH NOT FINAL
Extra Strength Acetaminophen (acetaminophen) NDC 51013-320
Acetaminophen 500 mg/1 · Tablet, Film coated · Oral · PuraCap Pharmaceutical LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51013-320-54 | 51013032054 | 15 POUCH in 1 CARTON (51013-320-54) / 2 TABLET, FILM COATED in 1 POUCHMarketed from Nov 9, 2017 |
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)
- Extra Strength Acetaminophen
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PuraCap Pharmaceutical LLC
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part343
- Marketing start
- Listing expires
- Identifiers
- Product ID 51013-320_1b2f1b11-905c-4c77-b609-ffae53749092SPL ID 1b2f1b11-905c-4c77-b609-ffae53749092SPL set ID f3c57374-1408-4459-a4de-ad12c2fc6b61RxCUI 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
N451013032054followed by a unit qualifier and the quantityPackage 51013-0320-54. 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: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| 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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-034 |
| Doans Extra Strengthmagnesium salicylate | Magnesium salicylate 580 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 55741-224 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-040 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc | 54738-111 |
| Chewable Acetaminophen Childrensacetaminophen | Acetaminophen 80 mg/1 | Tablet, ChewableOral | Richmond Pharmaceuticals, Inc. | 54738-092 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | CVS PHARMACY, INC. | 69842-390 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-540 |
| Aspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Richmond Pharmaceuticals, Inc. | 54738-128 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-541 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-548 |
| Aspirin | Aspirin 81 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-559 |
| Acetaminophen Diphenhydramine HCl | Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1 | TabletOral | Chain Drug Consortium,LLC | 68016-654 |
| Acetaminophen Capletsacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Breeden Brothers, LLC | 70729-001 |
| Acetaminophen Capletsacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Breeden Brothers, LLC | 70729-175 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-010 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-014 |
| 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 |
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