Prescription drug · ANDA
hydrocodone bitartrate and acetaminophen NDC 72162-1997
Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1997-1 | 72162199701 | 100 TABLET in 1 BOTTLE (72162-1997-1)Marketed from Jun 17, 2019 | |
| 72162-1997-5 | 72162199705 | 500 TABLET in 1 BOTTLE (72162-1997-5)Marketed from Jun 17, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 7.5 mg/1Acetaminophen — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207509
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72162-1997_cdbb3913-8f02-4e48-b0a1-6da8e8900215SPL ID cdbb3913-8f02-4e48-b0a1-6da8e8900215SPL set ID afdc6256-f7d0-404b-a377-328250ab29ffRxCUI 856992UNII 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
N472162199701followed by a unit qualifier and the quantityPackage 72162-1997-01. 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS ], reserve opioid analgesics, including Hydrocodone Bitartrate for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207509
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 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1177 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1179 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1184 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1180 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1181 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1183 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1996 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1998 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Eywa Pharma Inc | 71930-042 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Eywa Pharma Inc | 71930-043 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 300 mg/1 | TabletOral | Eywa Pharma Inc | 71930-044 |