Over-the-counter drug · NDA
Guaifenesin and Pseudoephedrine Hydrochloride NDC 0363-0077
Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 · Tablet, Extended release · Oral · WALGREEN COMPANY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0077-18 | 0036300771800363007718 | 1 BLISTER PACK in 1 CARTON (0363-0077-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 1, 2017 | |
| 0363-0077-36 | 0036300773600363007736 | 2 BLISTER PACK in 1 CARTON (0363-0077-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 1, 2017 |
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)
- Guaifenesin and Pseudoephedrine Hydrochloride
- Generic name (nonproprietary)
- guaifenesin and pseudoephedrine hydrochloride
- Active ingredients
- Guaifenesin — 600 mg/1Pseudoephedrine hydrochloride — 60 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- WALGREEN COMPANYNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021585
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 0363-0077_23bd928b-a15a-4da4-80c3-c599113f8376SPL ID 23bd928b-a15a-4da4-80c3-c599113f8376SPL set ID 310d14be-e7ea-44b8-8b04-cffa39440d50RxCUI 1305603UNII 495W7451VQ, 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
N400363007718followed by a unit qualifier and the quantityPackage 00363-0077-18. 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 0363-0077
- What is NDC 0363-0077?
- 0363-0077 is the product NDC for Guaifenesin and Pseudoephedrine Hydrochloride, Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 tablet, 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?
- Guaifenesin and Pseudoephedrine Hydrochloride.
- What is the active ingredient?
- Guaifenesin, 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 Guaifenesin and Pseudoephedrine Hydrochloride?
- 2 other product NDCs are listed under this name. See all Guaifenesin 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 Guaifenesin 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) |
|---|---|---|---|---|---|
| Guaifenesin and Pseudoephedrine Hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | PUBLIX SUPER MARKETS, INC | 41415-994 | 41415-0994-1841415-0994-36 |
| Guaifenesin and Pseudoephedrine Hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | STRATEGIC SOURCING SERVICES LLC | 62011-0475 | 62011-0475-01 |
Other NDCs under NDA 021585
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 |
|---|---|---|---|---|
| Mucinex Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-1075 |
| Mucinex Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-1076 |
| Mucinex Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Reckitt Benckiser LLC | 63824-057 |
| Mucinex D Maximum Strengthguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Reckitt Benckiser LLC | 63824-041 |