Prescription drug · ANDA
Hydrocodone Bitartrate and Acetaminophen NDC 67296-2201
Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2201-1 | 6729622010167296220101 | 4 TABLET in 1 BOTTLE (67296-2201-1)Marketed from Jul 13, 2018 | |
| 67296-2201-2 | 6729622010267296220102 | 6 TABLET in 1 BOTTLE (67296-2201-2)Marketed from Jul 13, 2018 | |
| 67296-2201-3 | 6729622010367296220103 | 10 TABLET in 1 BOTTLE (67296-2201-3)Marketed from Jul 13, 2018 | |
| 67296-2201-4 | 6729622010467296220104 | 15 TABLET in 1 BOTTLE (67296-2201-4)Marketed from Jul 13, 2018 | |
| 67296-2201-5 | 6729622010567296220105 | 20 TABLET in 1 BOTTLE (67296-2201-5)Marketed from Jul 13, 2018 | |
| 67296-2201-6 | 6729622010667296220106 | 30 TABLET in 1 BOTTLE (67296-2201-6)Marketed from Jul 13, 2018 | |
| 67296-2201-7 | 6729622010767296220107 | 40 TABLET in 1 BOTTLE (67296-2201-7)Marketed from Jul 13, 2018 | |
| 67296-2201-8 | 6729622010867296220108 | 12 TABLET in 1 BOTTLE (67296-2201-8)Marketed from Jul 13, 2018 |
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 — 5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Redpharm DrugNDC labeler code 67296
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210211
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 67296-2201_4c1c4d8f-040e-4960-e063-6294a90afe65SPL ID 4c1c4d8f-040e-4960-e063-6294a90afe65SPL set ID 46c13d54-b181-4da2-e063-6294a90ab5c5RxCUI 857002UNII NO70W886KK, 362O9ITL9DUPC 0371930019524, 0371930020124, 0371930021527, 0371930021138, 0371930020520, 0371930021121, 0371930020131, 0371930019128
- 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
N467296220101followed by a unit qualifier and the quantityPackage 67296-2201-01. 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 Tablet is 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 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 shoul…
Excerpt only. Read the full label for complete information.
About NDC 67296-2201
- What is NDC 67296-2201?
- 67296-2201 is the product NDC for Hydrocodone Bitartrate and Acetaminophen, Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Redpharm Drug. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocodone Bitartrate and Acetaminophen.
- What is the active ingredient?
- Hydrocodone bitartrate, Acetaminophen.
- Who is the labeler?
- Redpharm Drug, NDC labeler code 67296. 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 Acetaminophen?
- 201 other product NDCs are listed under this name. See all Hydrocodone Bitartrate and Acetaminophen 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 Acetaminophen 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 Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-873 | 60760-0873-3060760-0873-60 |
| Hydrocodone Bitartrate and Acetaminophen | Acetaminophen 325 mg/1; Hydrocodone bitartrate 10 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-872 | 60760-0872-3060760-0872-60 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-442 | 64380-0442-01 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-440 | 64380-0440-01 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-441 | 64380-0441-01 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Proficient Rx LP | 82804-306 | 82804-0306-12 |
| Hydrocodone Bitartrate And Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-870 | 60760-0870-3060760-0870-60 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-940 | 31722-0940-01 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-942 | 31722-0942-0131722-0942-05 |
| Hydrocodone Bitartrate And Acetaminophen | Hydrocodone bitartrate 10 mg/15mL; Acetaminophen 300 mg/15mL | LiquidOral | Hikma Pharmaceuticals USA Inc. | 0054-0843 | 00054-0843-63 |
Other NDCs under ANDA 210211
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 | American Health Packaging | 60687-396 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | American Health Packaging | 60687-407 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | American Health Packaging | 60687-418 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1938 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1939 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1940 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8885 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8886 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2494 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2645 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3447 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1970 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2116 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2144 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Eywa Pharma Inc | 71930-019 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Eywa Pharma Inc | 71930-020 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Eywa Pharma Inc | 71930-021 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1989 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1990 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1991 |
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