Prescription drug · ANDA
Hydrocodone/APAP NDC 72189-407
Acetaminophen 325 mg/1; Hydrocodone bitartrate 5 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-407-30 | 72189040730 | 30 TABLET in 1 BOTTLE (72189-407-30)Marketed from Dec 28, 2022 | |
| 72189-407-60 | 72189040760 | 60 TABLET in 1 BOTTLE (72189-407-60)Marketed from Dec 28, 2022 | |
| 72189-407-72 | 72189040772 | 120 TABLET in 1 BOTTLE (72189-407-72)Marketed from Dec 28, 2022 | |
| 72189-407-90 | 72189040790 | 90 TABLET in 1 BOTTLE (72189-407-90)Marketed from Dec 28, 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/APAP
- Generic name (nonproprietary)
- hydrocodone/apap
- Active ingredients
- Acetaminophen — 325 mg/1Hydrocodone bitartrate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040409
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72189-407_2c4cf13b-5454-0aa9-e063-6394a90ac235SPL ID 2c4cf13b-5454-0aa9-e063-6394a90ac235SPL set ID f0e66441-668a-7ab8-e053-2995a90aba4fRxCUI 857002UNII 362O9ITL9D, NO70W886KK
- 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
N472189040730followed by a unit qualifier and the quantityPackage 72189-0407-30. 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 acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040409
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 Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Proficient Rx LP | 82804-116 |
| Hydrocodone Bitartrate And Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | A-S Medication Solutions | 50090-1778 |
| Hydrocodone Bitartrate And Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-590 |
| Hydrocodone Bitartrate And Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-870 |
| Hydrocodone Bitartrate And Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | RedPharm Drug, Inc | 67296-1890 |
| Hydrocodone Bitartrate And Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | SpecGx LLC | 0406-0123 |
| Hydrocodone Bitartrate And Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Quality Care Products, LLC | 55700-992 |