Over-the-counter drug · ANDA
Leader 12 Hour Sinus Nasal Decongestant (Pseudoephedrine hcl) NDC 70000-0735
Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · Cardinal Health 110, LLC. dba Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0735-1 | 7000007350170000073501 | 10 BLISTER PACK in 1 CARTON (70000-0735-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 7, 2025 |
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)
- Leader 12 Hour Sinus Nasal Decongestant
- Generic name (nonproprietary)
- pseudoephedrine hcl
- Active ingredients
- Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
- 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 70000-0735_f020d2ca-7401-4062-9097-17459e554fbcSPL ID f020d2ca-7401-4062-9097-17459e554fbcSPL set ID a647e822-c4dd-46fd-bd55-bd9226990357RxCUI 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
N470000073501followed by a unit qualifier and the quantityPackage 70000-0735-01. 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.
About NDC 70000-0735
- What is NDC 70000-0735?
- 70000-0735 is the product NDC for Leader 12 Hour Sinus Nasal Decongestant, Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Leader 12 Hour Sinus Nasal Decongestant (Pseudoephedrine HCl).
- What is the active ingredient?
- Pseudoephedrine hydrochloride.
- Who is the labeler?
- Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Leader 12 Hour Sinus Nasal Decongestant?
- 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 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 |
| 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 |
| Nasal Decongestant Dpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Walgreen Company | 0363-3301 |
| 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 |