Over-the-counter drug · ANDA
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride NDC 51316-015
Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Extended release · Oral · CVS Health Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-015-20 | 5131600152051316001520 | 4 BLISTER PACK in 1 CARTON (51316-015-20) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 17, 2023 | |
| 51316-015-30 | 5131600153051316001530 | 6 BLISTER PACK in 1 CARTON (51316-015-30) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 17, 2023 |
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)
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Generic name (nonproprietary)
- fexofenadine hydrochloride and pseudoephedrine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 60 mg/1Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- CVS Health CorpNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215434
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51316-015_d973f66a-509e-62a5-ddbf-eb54b229ce9aSPL ID d973f66a-509e-62a5-ddbf-eb54b229ce9aSPL set ID b009e6b1-57da-a002-1a9e-38a96cc041f1RxCUI 997406UNII 2S068B75ZU, 6V9V2RYJ8NUPC 0050428290538
- Pharmacologic class
- Histamine-1 Receptor Antagonist; alpha-Adrenergic Agonist
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
N451316001520followed by a unit qualifier and the quantityPackage 51316-0015-20. 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)
Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relives nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose
Excerpt only. Read the full label for complete information.
About NDC 51316-015
- What is NDC 51316-015?
- 51316-015 is the product NDC for Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride, Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, extended release, listed with the FDA by CVS Health Corp. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride.
- What is the active ingredient?
- Fexofenadine hydrochloride, Pseudoephedrine hydrochloride.
- Who is the labeler?
- CVS Health Corp, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride?
- 21 other product NDCs are listed under this name. See all Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 180 mg/1; Pseudoephedrine hydrochloride 240 mg/1 | Tablet, Film coated, Extended releaseOral | WALGREEN CO. | 0363-0270 | 00363-0270-10 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 180 mg/1; Pseudoephedrine hydrochloride 240 mg/1 | Tablet, Film coated, Extended releaseOral | Aurohealth LLC | 58602-844 | 58602-0844-6058602-0844-6658602-0844-85 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Rugby Laboratories | 0536-1431 | 00536-1431-0700536-1431-34 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health | 70000-0677 | 70000-0677-0170000-0677-02 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS Pharmacy, Inc. | 51316-007 | 51316-0007-6751316-0007-84 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Walgreens Company | 0363-0044 | 00363-0044-2000363-0044-30 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Rite Aid Corporation | 11822-0021 | 11822-0021-0411822-0021-06 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-097 | 30142-0097-20 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services, LLC | 70677-1010 | 70677-1010-01 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Wal-mart Stores, Inc. | 79903-108 | 79903-0108-2079903-0108-30 |
All 22 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride NDCs
Other NDCs under ANDA 215434
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 |
|---|---|---|---|---|
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Walgreens Company | 0363-0044 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Rite Aid Corporation | 11822-0021 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-097 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services, LLC | 70677-1010 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Wal-mart Stores, Inc. | 79903-108 |