Prescription drug · ANDA
Hydrocodone Bitartrate and Homatropine Methylbromide NDC 43386-118
Hydrocodone bitartrate 5 mg/1; Homatropine methylbromide 1.5 mg/1 · Tablet · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-118-01 | 43386011801 | 100 TABLET in 1 BOTTLE (43386-118-01)Marketed from Sep 23, 2014 · Sample package | |
| 43386-118-03 | 43386011803 | 30 TABLET in 1 BOTTLE (43386-118-03)Marketed from Sep 23, 2014 · 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/1Homatropine methylbromide — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals,Inc.NDC labeler code 43386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091528
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 43386-118_116df522-26b7-42de-8c0b-16cc60c2e764SPL ID 116df522-26b7-42de-8c0b-16cc60c2e764SPL set ID 41ac90b3-f007-4eb2-9d41-ea626ced2017RxCUI 992656UNII NO70W886KK, 68JRS2HC1CUPC 0343386118038
- 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
N443386011801followed by a unit qualifier and the quantityPackage 43386-0118-01. 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 Tablets are indicated for the symptomatic relief of cough in patients 18 years of age and older. Important 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 Tablets for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an a…
Excerpt only. Read the full label for complete information.
About NDC 43386-118
- What is NDC 43386-118?
- 43386-118 is the product NDC for Hydrocodone Bitartrate and Homatropine Methylbromide, Hydrocodone bitartrate 5 mg/1; Homatropine methylbromide 1.5 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 2 package NDCs, 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?
- Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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/5mL; Homatropine methylbromide 1.5 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1036 | 00121-1036-40 |
| 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 |
Other NDCs under ANDA 091528
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 | Novel Laboratories, Inc. | 40032-118 |