Prescription drug · ANDA
Hydrocodone Bitartrate and Acetaminophen NDC 63187-658
Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC DirectoryProduct NDC (as listed)63187-658Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0658Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-658-12 | 6318706581263187065812 | 12 TABLET in 1 BOTTLE (63187-658-12)Marketed from Mar 3, 2021 | |
| 63187-658-15 | 6318706581563187065815 | 15 TABLET in 1 BOTTLE (63187-658-15)Marketed from Mar 1, 2016 | |
| 63187-658-20 | 6318706582063187065820 | 20 TABLET in 1 BOTTLE (63187-658-20)Marketed from Mar 1, 2016 | |
| 63187-658-30 | 6318706583063187065830 | 30 TABLET in 1 BOTTLE (63187-658-30)Marketed from May 1, 2017 | |
| 63187-658-60 | 6318706586063187065860 | 60 TABLET in 1 BOTTLE (63187-658-60)Marketed from Jan 1, 2018 | |
| 63187-658-90 | 6318706589063187065890 | 90 TABLET in 1 BOTTLE (63187-658-90)Marketed from Mar 1, 2016 |
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 — 7.5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201013
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 63187-658_53d10ccb-24f8-4d73-89ee-22bd08590f0aSPL ID 53d10ccb-24f8-4d73-89ee-22bd08590f0aSPL set ID e6711f26-a01d-43e8-882a-d58561e4b67fRxCUI 857005UNII NO70W886KK, 362O9ITL9DUPC 0363187658120
- 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
N463187065812followed by a unit qualifier and the quantityPackage 63187-0658-12. 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 USP are, indicated for the relief of moderate to moderately severe pain.
Excerpt only. Read the full label for complete information.
About NDC 63187-658
- What is NDC 63187-658?
- 63187-658 is the product NDC for Hydrocodone Bitartrate and Acetaminophen, Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 6 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?
- Proficient Rx LP, NDC labeler code 63187. 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?
- 202 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 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 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 | Proficient Rx LP | 82804-306 | 82804-0306-12 |
| 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 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 10 mg/15mL; Acetaminophen 300 mg/15mL | LiquidOral | Hikma Pharmaceuticals USA Inc. | 0054-0843 | 00054-0843-63 |
Other NDCs under ANDA 201013
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 | Aurolife Pharma, LLC | 13107-019 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Aurolife Pharma, LLC | 13107-020 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Aurolife Pharma, LLC | 13107-021 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Proficient Rx LP | 63187-375 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Proficient Rx LP | 63187-778 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-319 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4801 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4853 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4941 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0108 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1271 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1339 |