Prescription drug · ANDA
Hydrocodone Bitartrate and Homatropine Methylbromide NDC 10702-055
Hydrocodone bitartrate 5 mg/1; Homatropine methylbromide 1.5 mg/1 · Tablet · Oral · KVK-Tech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10702-055-01 | 10702005501 | 100 TABLET in 1 BOTTLE (10702-055-01)Marketed from Aug 7, 2017 | |
| 10702-055-03 | 10702005503 | 30 TABLET in 1 BOTTLE (10702-055-03)Marketed from Aug 7, 2017 | |
| 10702-055-09 | 10702005509 | 90 TABLET in 1 BOTTLE (10702-055-09)Marketed from Aug 7, 2017 | |
| 10702-055-10 | 10702005510 | 1000 TABLET in 1 BOTTLE (10702-055-10)Marketed from Aug 7, 2017 |
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/1Homatropine methylbromide — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- KVK-Tech, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207176
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 10702-055_59e5212e-8d4c-692e-e063-6394a90ae2caSPL ID 59e5212e-8d4c-692e-e063-6394a90ae2caSPL set ID 26d7c90c-5e6b-4bdb-b06f-c76173a01c21RxCUI 992656UNII NO70W886KK, 68JRS2HC1C
- 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
N410702005501followed by a unit qualifier and the quantityPackage 10702-0055-01. 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 . 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, not…
Excerpt only. Read the full label for complete information.