Over-the-counter drug · ANDA
Equaline 12 Hour Decongestant (pseudoephedrine hydrochloride) NDC 41163-054
Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · United Natural Foods, Inc. dba UNFI
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41163-054-60 | 41163005460 | 20 BLISTER PACK in 1 CARTON (41163-054-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 10, 2004 |
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)
- Equaline 12 Hour Decongestant
- Generic name (nonproprietary)
- pseudoephedrine hydrochloride
- Active ingredients
- Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075153
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 41163-054_8f2a455a-ff19-4cea-8e88-f440971bfe58SPL ID 8f2a455a-ff19-4cea-8e88-f440971bfe58SPL set ID bd5c2093-f812-4dfe-80ea-68cb4e65a09cRxCUI 1049154UNII 6V9V2RYJ8N
- Pharmacologic class
- 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
N441163005460followed by a unit qualifier and the quantityPackage 41163-0054-60. 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 nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves sinus congestion and pressure
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075153
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 |
|---|---|---|---|---|
| Nasal Decongestant Dpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Walgreen Company | 0363-3301 |
| equate sinus 12 hourpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Wal-Mart Stores Inc | 49035-508 |
| leader 12 hour nasal decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0475 |
| CareOne Nasal and Sinus Decongestantpseudoephedrine hcl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | American Sales Company | 41520-429 |
| Sudafed Sinus Congestion 12 Hourpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-4629 |
| nasal decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Meijer Distribution Inc | 41250-809 |
| Sudafed Sinus Congestion 12 Hourpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Kenvue Brands LLC | 50580-242 |
| nasal decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Publix Super Markets Inc | 56062-054 |
| topcare 12 hour decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Topco Associates LLC | 36800-054 |
| sinus pressure and congestion relief maximum strengthpseudoephedrine hcl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Rite Aid Corporation | 11822-0650 |
| pseudoephedrine hydrochloridepseudoephedrine hcl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Padagis Israel Pharmaceuticals Ltd | 45802-107 |
| 12 Hour Nasal Decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS Pharmacy | 59779-703 |
| Good Sense Suphedrine 12 Hourpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | L. Perrigo Company | 0113-0054 |
| SudoGest 12 Hourpseudoephedrine hcl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6754 |
| sinus 12 hourpseudoephedrine hcl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | L. Perrigo Company | 0113-2017 |
| nasal decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | HyVee Inc | 42507-054 |
| Leader 12 Hour Sinus Nasal Decongestantpseudoephedrine hcl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0735 |
| sinus and nasal decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-616 |
| good neighbor pharmacy nasal decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Amerisource Bergen | 24385-054 |