Over-the-counter drug · ANDA
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride NDC 47335-724
Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)47335-724Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47335-0724Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-724-64 | 4733507246447335072464 | 6 BLISTER PACK in 1 CARTON (47335-724-64) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60)Marketed from Mar 1, 2018 | |
| 47335-724-66 | 4733507246647335072466 | 2 BLISTER PACK in 1 CARTON (47335-724-66) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60)Marketed from Mar 1, 2018 | |
| 47335-724-75 | 4733507247547335072475 | 4 BLISTER PACK in 1 CARTON (47335-724-75) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60)Marketed from Mar 1, 2018 | |
| 47335-724-83 | 4733507248347335072483 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-724-83)Marketed from Mar 1, 2018 | |
| 47335-724-94 | 4733507249447335072494 | 1 BLISTER PACK in 1 CARTON (47335-724-94) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 1, 2018 | |
| 47335-724-95 | 4733507249547335072495 | 3 BLISTER PACK in 1 CARTON (47335-724-95) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 1, 2018 | |
| 47335-724-99 | 4733507249947335072499 | 2 BLISTER PACK in 1 CARTON (47335-724-99) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 1, 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)
- 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, Film coated, Extended release
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090818
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 47335-724_554fd38b-a6cf-4b55-bfb2-ee7cb3ef48e8SPL ID 554fd38b-a6cf-4b55-bfb2-ee7cb3ef48e8SPL set ID 8afc0167-17bf-4ccd-91c9-8fb9c4e241c1RxCUI 997406UNII 2S068B75ZU, 6V9V2RYJ8NUPC 0347335724837
- 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
N447335072464followed by a unit qualifier and the quantityPackage 47335-0724-64. 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 these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves 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 47335-724
- What is NDC 47335-724?
- 47335-724 is the product NDC for Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride, Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 7 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 | CVS Health Corp | 51316-015 | 51316-0015-2051316-0015-30 |
| 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 |
All 22 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride NDCs
Other NDCs under ANDA 090818
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, Film coated, Extended releaseOral | walgreens | 0363-2110 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | H E B | 37808-999 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | PUBLIX SUPER MARKETS, INC | 41415-995 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | AmeriSource Bergen | 46122-694 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Ohm Laboratories Inc. | 51660-037 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 69842-973 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS Pharmacy | 69842-990 |