Prescription drug · NDA AUTHORIZED GENERIC
Hydrocodone Bitartrate and Homatropine Methylbromide NDC 0121-1036
Hydrocodone bitartrate 5 mg/5mL; Homatropine methylbromide 1.5 mg/5mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-1036-40 | 0012110364000121103640 | 4 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05)Marketed from Aug 5, 2024 |
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)
- 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
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 005213
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0121-1036_17bce1b5-fe40-42c4-b167-51f48ea47c9eSPL ID 17bce1b5-fe40-42c4-b167-51f48ea47c9eSPL set ID 71319a6f-aaf4-4bc5-8b40-a16c6f139be6RxCUI 992668UNII 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
N400121103640followed by a unit qualifier and the quantityPackage 00121-1036-40. 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…
Excerpt only. Read the full label for complete information.
About NDC 0121-1036
- What is NDC 0121-1036?
- 0121-1036 is the product NDC for Hydrocodone Bitartrate and Homatropine Methylbromide, Hydrocodone bitartrate 5 mg/5mL; Homatropine methylbromide 1.5 mg/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocodone Bitartrate and Homatropine Methylbromide.
- What is the active ingredient?
- Hydrocodone bitartrate, Homatropine methylbromide.
- Who is the labeler?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydrocodone Bitartrate and Homatropine Methylbromide?
- 7 other product NDCs are listed under this name. See all Hydrocodone Bitartrate and Homatropine Methylbromide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrocodone Bitartrate and Homatropine Methylbromide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone bitartrate 5 mg/1; Homatropine methylbromide 1.5 mg/1 | TabletOral | Genus Lifesciences Inc. | 64950-206 | 64950-0206-0364950-0206-10 |
| Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone bitartrate 5 mg/5mL; Homatropine methylbromide 1.5 mg/5mL | SolutionOral | Genus Lifesciences Inc. | 64950-371 | 64950-0371-47 |
| Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone bitartrate 5 mg/1; Homatropine methylbromide 1.5 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-055 | 10702-0055-0110702-0055-0310702-0055-09+1 more |
| Hydrocodone Bitartrate and Homatropine Methylbromidehydrocodone bitartrate and homatropine methylbromide oral solution | Hydrocodone bitartrate 5 mg/5mL; Homatropine methylbromide 1.5 mg/5mL | LiquidOral | KVK-Tech, Inc. | 10702-150 | 10702-0150-16 |
| Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone bitartrate 5 mg/5mL; Homatropine methylbromide 1.5 mg/5mL | SyrupOral | Novel Laboratories, Inc. | 40032-810 | 40032-0810-05 |
| Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone bitartrate 5 mg/1; Homatropine methylbromide 1.5 mg/1 | TabletOral | Novel Laboratories, Inc. | 40032-118 | 40032-0118-0340032-0118-2440032-0118-26 |
| Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone bitartrate 5 mg/1; Homatropine methylbromide 1.5 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-118 | 43386-0118-0143386-0118-03 |
Other NDCs under NDA 005213
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 |
|---|---|---|---|---|
| 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 | Genus Lifesciences Inc. | 64950-371 |