Over-the-counter drug · NDA
Feverall Infants (Acetaminophen) NDC 51672-2114
Acetaminophen 80 mg/1 · Suppository · Rectal · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-2114-2 | 51672211402 | 6 BLISTER PACK in 1 CARTON (51672-2114-2) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2114-0)Marketed from Dec 12, 2013 | |
| 51672-2114-4 | 51672211404 | 50 BLISTER PACK in 1 CARTON (51672-2114-4) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2114-0)Marketed from Dec 12, 2013 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Feverall InfantsSuffix: Infants
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 80 mg/1
- Dosage form
- Suppository
- Route
- Rectal
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018337
- Marketing start
- Listing expires
- Identifiers
- Product ID 51672-2114_575ce0e3-78a7-b636-e063-6294a90aba2dSPL ID 575ce0e3-78a7-b636-e063-6294a90aba2dSPL set ID 3ade895b-5dca-4d81-9415-8091923162ffRxCUI 198445, 209531UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N451672211402followed by a unit qualifier and the quantityPackage 51672-2114-02. 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, pains, and headache
Excerpt only. Read the full label for complete information.
About NDC 51672-2114
- What is NDC 51672-2114?
- 51672-2114 is the product NDC for Feverall Infants (acetaminophen), Acetaminophen 80 mg/1 suppository, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Feverall Infants (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Feverall Infants?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 018337
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 |
|---|---|---|---|---|
| Feverall Childrensacetaminophen | Acetaminophen 120 mg/1 | SuppositoryRectal | Sun Pharmaceutical Industries, Inc. | 51672-2115 |
| Feverall Jr. Strengthacetaminophen | Acetaminophen 325 mg/1 | SuppositoryRectal | Sun Pharmaceutical Industries, Inc. | 51672-2116 |