Prescription drug · ANDA
Hydrocodone Bitartrate And Acetaminophen NDC 60429-590
Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60429-590-01 | 60429059001 | 100 TABLET in 1 BOTTLE (60429-590-01)Marketed from May 9, 2019 | |
| 60429-590-05 | 60429059005 | 500 TABLET in 1 BOTTLE (60429-590-05)Marketed from May 9, 2019 |
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 Acetaminophen
- Generic name (nonproprietary)
- hydrocodone bitartrate and acetaminophen
- Active ingredients
- Hydrocodone bitartrate — 5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040409
- Marketing start
- Marketing end
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 60429-590_28f3a26a-dadc-492c-e063-6294a90a817fSPL ID 28f3a26a-dadc-492c-e063-6294a90a817fSPL set ID 87ed3420-1697-6f42-e053-2995a90a1a5bRxCUI 856999, 857002, 857005UNII NO70W886KK, 362O9ITL9D
- 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
N460429059001followed by a unit qualifier and the quantityPackage 60429-0590-01. 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)
INDICATIONS AND USAGE 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, which can occur at any dosage or duration ( 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 Hydrocodone bitartrate and acetaminophen tablets…
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/APAP | Acetaminophen 325 mg/1; Hydrocodone bitartrate 5 mg/1 | TabletOral | Direct_Rx | 72189-407 |
| 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 |