Over-the-counter drug · ANDA
Nasal Decongestant D (Pseudoephedrine hydrochloride) NDC 0363-3301
Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · Walgreen Company
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0363-3301Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-3301Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-3301-52 | 0036333015200363330152 | 10 BLISTER PACK in 1 CARTON (0363-3301-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 6, 2022 | |
| 0363-3301-60 | 0036333016000363330160 | 20 BLISTER PACK in 1 CARTON (0363-3301-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 6, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Nasal Decongestant D
- Generic name (nonproprietary)
- pseudoephedrine hydrochloride
- Active ingredients
- Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Walgreen CompanyNDC labeler code 0363
- 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 0363-3301_b586b690-4546-45d3-90f8-8c0debdbdd13SPL ID b586b690-4546-45d3-90f8-8c0debdbdd13
- 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
N400363330152followed by a unit qualifier and the quantityPackage 00363-3301-52. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0363-3301
- What is NDC 0363-3301?
- 0363-3301 is the product NDC for Nasal Decongestant D (pseudoephedrine hydrochloride), Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Walgreen Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nasal Decongestant D (Pseudoephedrine Hydrochloride).
- What is the active ingredient?
- Pseudoephedrine hydrochloride.
- Who is the labeler?
- Walgreen Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nasal Decongestant D?
- 1 other product NDC are listed under this name. See all Nasal Decongestant D NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nasal Decongestant D products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nasal Decongestant Dpseudoephedrine hcl | Pseudoephedrine hydrochloride 30 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1214 | 00363-1214-0800363-1214-2200363-1214-46 |
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 |
|---|---|---|---|---|
| 12 Hour Nasal Decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS Pharmacy | 59779-703 |
| CareOne Nasal and Sinus Decongestantpseudoephedrine hcl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | American Sales Company | 41520-429 |
| Equaline 12 Hour Decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | United Natural Foods, Inc. dba UNFI | 41163-054 |
| equate sinus 12 hourpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Wal-Mart Stores Inc | 49035-508 |
| good neighbor pharmacy nasal decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Amerisource Bergen | 24385-054 |
| Good Sense Suphedrine 12 Hourpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | L. Perrigo Company | 0113-0054 |
| leader 12 hour nasal decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0475 |
| 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 |
| nasal decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Meijer Distribution Inc | 41250-809 |
| nasal decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | HyVee Inc | 42507-054 |
| nasal decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Publix Super Markets Inc | 56062-054 |
| pseudoephedrine hydrochloridepseudoephedrine hcl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Padagis Israel Pharmaceuticals Ltd | 45802-107 |
| sinus 12 hourpseudoephedrine hcl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | L. Perrigo Company | 0113-2017 |
| sinus and nasal decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-616 |
| sinus pressure and congestion relief maximum strengthpseudoephedrine hcl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Rite Aid Corporation | 11822-0650 |
| Sudafed Sinus Congestion 12 Hourpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-4629 |
| Sudafed Sinus Congestion 12 Hourpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Kenvue Brands LLC | 50580-242 |
| SudoGest 12 Hourpseudoephedrine hcl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6754 |
| topcare 12 hour decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Topco Associates LLC | 36800-054 |