Hydrocodone Bitartrate and Homatropine Methylbromide NDC 64950-371

NDC codes

FDA NDC Directory

Product NDC (as listed)64950-371Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64950-0371Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
64950-371-47	64950037147	473 mL in 1 BOTTLE (64950-371-47)Marketed from Aug 10, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Hydrocodone Bitartrate and Homatropine Methylbromide
Generic name (nonproprietary): hydrocodone bitartrate and homatropine methylbromide
Active ingredients: Hydrocodone bitartrate — 5 mg/5mLHomatropine methylbromide — 1.5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Genus Lifesciences Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 005213
Marketing start: Aug 10, 2022
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 64950-371_d2e40c65-781a-410f-a6e1-5fe01b76c24fSPL ID d2e40c65-781a-410f-a6e1-5fe01b76c24fSPL set ID 320ff639-9854-407b-9bbd-a035c4f173e1RxCUI 992656, 992668UNII 68JRS2HC1C, NO70W886KKUPC 0364950206036
Pharmacologic class: Opioid 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

N464950037147 followed by a unit qualifier and the quantity

Package 64950-0371-47. 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 May 7, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use : Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ] . Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4) ] . Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1) ], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, n…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 005213

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 005213
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone bitartrate 5 mg/1; Homatropine methylbromide 1.5 mg/1	TabletOral	Genus Lifesciences Inc.	64950-206
Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone bitartrate 5 mg/5mL; Homatropine methylbromide 1.5 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1036