Over-the-counter drug · OTC MONOGRAPH DRUG
Guaifenesin NDC 0904-5154
Guaifenesin 200 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0904-5154Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-5154Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-5154-60 | 00904515460 | 100 TABLET in 1 BOTTLE, PLASTIC (0904-5154-60)Marketed from Oct 5, 2009 |
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
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 0904-5154_9a9743de-1619-4d95-868f-d125b1d409e4SPL ID 9a9743de-1619-4d95-868f-d125b1d409e4SPL set ID aa662428-e61f-4e22-af4d-8cf63df68c99RxCUI 197741UNII 495W7451VQUPC 0309045154601
- Pharmacologic class
- Expectorant
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
N400904515460followed by a unit qualifier and the quantityPackage 00904-5154-60. 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 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Excerpt only. Read the full label for complete information.
About NDC 0904-5154
- What is NDC 0904-5154?
- 0904-5154 is the product NDC for Guaifenesin, Guaifenesin 200 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin.
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. 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?
- 62 other product NDCs are listed under this name. See all Guaifenesin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guaifenesin 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 | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-857 | 58602-0857-93 |
| Guaifenesinguaifenesin 400 mg | Guaifenesin 200 mg/1 | TabletOral | Zennova LLC | 81993-002 | 81993-0002-0181993-0002-0281993-0002-03+2 more |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | TOPCO ASSOCIATES LLC | 76162-031 | 76162-0031-56 |
| Guaifenesin | Guaifenesin 600 mg/1 | TabletOral | YYBA CORP | 73581-400 | 73581-0400-0273581-0400-07 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Sam's West Inc | 68196-960 | 68196-0960-56 |
| Guaifenesin | Guaifenesin 100 mg/5mL | LiquidOral | KESIN PHARMA CORPORATION | 81033-102 | 81033-0102-16 |
| Guaifenesin | Guaifenesin 100 mg/5mL | SolutionOral | American Health Packaging | 60687-852 | 60687-0852-17 |
| Guaifenesin | Guaifenesin 200 mg/10mL | SolutionOral | American Health Packaging | 60687-863 | 60687-0863-56 |
| Guaifenesin | Guaifenesin 300 mg/15mL | SolutionOral | American Health Packaging | 60687-874 | 60687-0874-16 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | GRANULES USA, INC. | 69848-018 | 69848-0018-16 |
Other NDCs under M 012
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 |
|---|---|---|---|---|
| topcare tussin cf maxacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Topco Associates LLC | 76162-000 |
| SEVERE CONGESTION and COUGH MAXdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/20mL + 2 more ingredients | LiquidOral | AptaPharma Inc. | 76281-517 |
| Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide, and doxylamine succinate | Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-304 |
| Quality Choice Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Chain Drug Marketing Association | 83324-194 |
| Pseudoephedrine Hydrochloride | Pseudoephedrine hydrochloride 60 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6728 |
| Nighttime Cold and Flu Liquidacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | TARGET CORPORATION | 11673-287 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | TARGET CORPORATION | 11673-494 |
| Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | KROGER COMPANY | 41226-272 |
| sinus pressure and pain peacetaminophen and phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, CoatedOral | GOODSENSE | 50804-220 |
| Mucinex Sinus-Max Severe Congestion Reliefacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Reckitt Benckiser LLC | 63824-201 |
| Oxymetazoline Hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | CHAIN DRUG MARKETING ASSOCIATION INC. | 63868-676 |
| Childrens Wal Tap Elixer Cold and Allergybrompheniramine maleate, phenylephrine hcl | Brompheniramine maleate 2 mg/10mL; Phenylephrine hydrochloride 5 mg/10mL | LiquidOral | Walgreens | 0363-0312 |
| Vicks NyQuil Kids BERRY COLD and COUGH plus RUNNY NOSEchlorpheniramine maleate, dextromethorphan hbr | Chlorpheniramine maleate 2 mg/15mL; Dextromethorphan hydrobromide 15 mg/15mL | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-779 |
| Night-Time Cold and Flu Reliefacetaminophen, doxylamine succinate, dextromethorphan hbr | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | HealthLife of USA | 69517-161 |
| Tylenol Sinus Severeacetaminophen | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | R J General Corporation | 70264-026 |
| Tussin Expectorantguaifenesin | Guaifenesin 100 mg/5mL | LiquidOral | AptaPharma, Inc. | 76281-507 |
| ValuMeds Allergy Relief Antihistamine Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1101 |
| Equate Severe Menthol Throat Dropmenthol | Menthol 20 mg/1 | LozengeOral | Walmart | 79903-254 |
| Nighttime Cold And Flu Relief Softgels Multi-Symptomacetaminophen, dextromethorphan hbr, doxylamine succinate | Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients | Capsule, Gelatin coatedOral | Advanced Rx LLC | 80513-302 |
| Vicks NyQuil-D COLD and SINUS plus SEVERE CONGESTIONacetaminophen, pseudoephedrine hcl, doxylamine succinate, dextromethorphan hbr | Doxylamine succinate 6.25 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | The Procter & Gamble Manufacturing Company | 84126-364 |
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