Hydrocodone Bitartrate and Homatropine Methylbromide NDC 40032-810

NDC codes

FDA NDC Directory

Product NDC (as listed)40032-810Labeler and product segments. Claims need a package NDC.

Product NDC at billing width40032-0810Add 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
40032-810-05	40032081005	473 mL in 1 BOTTLE (40032-810-05)Marketed from Feb 13, 2017 · Sample package

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: Syrup
Route: Oral
Labeler: Novel Laboratories, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203535
Marketing start: Feb 13, 2017
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 40032-810_c524711b-29fd-41d1-b026-072e7314b06aSPL ID c524711b-29fd-41d1-b026-072e7314b06aSPL set ID 4050ae05-7f1a-48b7-99b9-f8db8aa02741RxCUI 992668UNII NO70W886KK, 68JRS2HC1CUPC 0340032810056
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

N440032081005 followed by a unit qualifier and the quantity

Package 40032-0810-05. 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 Oct 8, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) are 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, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.1 )], reserve Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) for use in adult patients for whom the benefits of cough suppression are expected to outweigh th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)