Over-the-counter drug · ANDA
Leader Mucus Relief D NDC 70000-0719
guaifenesin, pseudoephedrine hydrochloride · Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Multilayer, Extended release · Oral · Cardinal Health 110, LLC. dba Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0719-1 | 7000007190170000071901 | 4 BLISTER PACK in 1 CARTON (70000-0719-1) / 6 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 8, 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 Mucus Relief D
- Generic name (nonproprietary)
- guaifenesin, pseudoephedrine hydrochloride
- Active ingredients
- Guaifenesin — 1200 mg/1Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Multilayer, 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 214407
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 70000-0719_1a7ee5d9-d68a-4df4-ac73-21002330b66aSPL ID 1a7ee5d9-d68a-4df4-ac73-21002330b66aSPL set ID 12971fb2-2314-4443-bf70-b7eb5859b148RxCUI 1244675UNII 495W7451VQ, 6V9V2RYJ8N
- Pharmacologic class
- Expectorant; 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
N470000071901followed by a unit qualifier and the quantityPackage 70000-0719-01. 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 • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure
Excerpt only. Read the full label for complete information.
About NDC 70000-0719
- What is NDC 70000-0719?
- 70000-0719 is the product NDC for Leader Mucus Relief D, Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, multilayer, 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 Mucus Relief D (Guaifenesin, pseudoephedrine hydrochloride).
- What is the active ingredient?
- Guaifenesin, 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 Mucus Relief D?
- 1 other product NDC are listed under this name. See all Leader Mucus Relief D NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Leader Mucus Relief 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) |
|---|---|---|---|---|---|
| Leader Mucus Relief Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0720 | 70000-0720-0170000-0720-02 |
Other NDCs under ANDA 214407
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 |
|---|---|---|---|---|
| equate mucus dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | WALMART INC. | 79903-125 |
| Equate Mucus Dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | WALMART INC. | 79903-388 |
| foster and thrive mucus relief dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1272 |
| foster and thrive mucus relief dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1273 |
| Leader Mucus Relief Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0720 |
| mucus Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | L. Perrigo Company | 0113-8307 |
| Mucus Dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | L. Perrigo Company | 0113-8911 |
| mucus dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Kroger Company | 30142-739 |
| mucus dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-345 |
| Mucus Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-878 |
| mucus Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | Meijer, Inc. | 79481-0119 |
| Mucus Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Meijer, Inc. | 79481-0709 |
| mucus relief dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | Walgreen Company | 0363-2389 |
| Mucus Relief Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Walgreen Company | 0363-8708 |
| mucus relief dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | H E B | 59640-300 |
| mucus relief dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | H E B | 59640-621 |
| nasal and chest decongestantguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | Publix Super Markets Inc | 56062-614 |
| Rugby Mucus Relief Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Rugby Laboratories | 0536-1449 |
| topcare mucus dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Topco Associates LLC | 76162-801 |