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 | 5101303205451013032054 | 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 LLCNDC labeler code 51013
- 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.
About NDC 51013-320
- What is NDC 51013-320?
- 51013-320 is the product NDC for Extra Strength Acetaminophen (acetaminophen), Acetaminophen 500 mg/1 tablet, film coated, listed with the FDA by PuraCap Pharmaceutical LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Extra Strength Acetaminophen (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- PuraCap Pharmaceutical LLC, NDC labeler code 51013. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Extra Strength Acetaminophen?
- 16 other product NDCs are listed under this name. See all Extra Strength Acetaminophen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Extra Strength 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) |
|---|---|---|---|---|---|
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-673 | 49483-0673-73 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | Capsule, Gelatin coatedOral | Pinnacle RX LLC | 87438-0001 | 87438-0001-01 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Grocery Outlet, Inc. | 85828-341 | 85828-0341-20 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 83934-673 | 83934-0673-73 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4065 | 68788-4065-0168788-4065-0268788-4065-03+1 more |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8873 | 68788-8873-0168788-8873-0268788-8873-03+1 more |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Geri-Care Pharmaceutical Corp | 57896-219 | 57896-0219-0157896-0219-0557896-0219-10+2 more |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3907 | 68071-3907-0268071-3907-0368071-3907-05 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREENS CO. | 0363-9084 | 00363-9084-15 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-697 | 49483-0697-43 |
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 low dose enteric coatedaspirin | Aspirin 81 mg/1 | Tablet, CoatedOral | Time-Cap Labs, Inc | 49483-387 |
| aspirin low dose enteric coatedaspirin | Aspirin 81 mg/1 | TabletOral | Time-Cap Labs, Inc | 49483-390 |
| Acetaminophen Capletsacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Breeden Brothers, LLC | 70729-001 |
| Acetaminophen Capletsacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Breeden Brothers, LLC | 70729-175 |
| Geritrex Aspirinaspirin | Aspirin 325 mg/1 | Tablet, CoatedOral | Geritrex LLC | 54162-940 |
| Pain Relief PMacetaminophen pm | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Velocity Pharma | 76168-119 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Velocity Pharma LLC | 76168-120 |
| CounterAct PMacetaminophen and diphenhydramine | Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1 | TabletOral | Melaleuca, Inc. | 54473-304 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-238 |
| 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 |
| 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 |
| 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 |
| 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 |
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