Prescription drug · ANDA
Oxycodone And Acetaminophen NDC 71335-1959
Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1959-1 | 7133519590171335195901 | 21 TABLET in 1 BOTTLE (71335-1959-1)Marketed from May 31, 2024 | |
| 71335-1959-2 | 7133519590271335195902 | 36 TABLET in 1 BOTTLE (71335-1959-2)Marketed from Sep 30, 2021 | |
| 71335-1959-3 | 7133519590371335195903 | 20 TABLET in 1 BOTTLE (71335-1959-3)Marketed from May 31, 2024 | |
| 71335-1959-4 | 7133519590471335195904 | 30 TABLET in 1 BOTTLE (71335-1959-4)Marketed from Oct 26, 2021 | |
| 71335-1959-5 | 7133519590571335195905 | 45 TABLET in 1 BOTTLE (71335-1959-5)Marketed from May 31, 2024 | |
| 71335-1959-6 | 7133519590671335195906 | 60 TABLET in 1 BOTTLE (71335-1959-6)Marketed from Oct 7, 2021 | |
| 71335-1959-7 | 7133519590771335195907 | 90 TABLET in 1 BOTTLE (71335-1959-7)Marketed from Oct 26, 2021 | |
| 71335-1959-8 | 7133519590871335195908 | 120 TABLET in 1 BOTTLE (71335-1959-8)Marketed from Nov 10, 2021 |
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)
- Oxycodone And Acetaminophen
- Generic name (nonproprietary)
- oxycodone and acetaminophen
- Active ingredients
- Oxycodone hydrochloride — 7.5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207419
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 71335-1959_6eeeb7dc-4dfc-4cb4-99cf-ffcee9112f00SPL ID 6eeeb7dc-4dfc-4cb4-99cf-ffcee9112f00SPL set ID 88d05136-7b04-4b25-af1c-6bc72fdbcbd7RxCUI 1049225UNII C1ENJ2TE6C, 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
N471335195901followed by a unit qualifier and the quantityPackage 71335-1959-01. 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 Oxycodone 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 Oxycodone 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 Oxycodone and Acetaminophen Tablets should not be used for an extended peri…
Excerpt only. Read the full label for complete information.
About NDC 71335-1959
- What is NDC 71335-1959?
- 71335-1959 is the product NDC for Oxycodone And Acetaminophen, Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxycodone And Acetaminophen.
- What is the active ingredient?
- Oxycodone hydrochloride, Acetaminophen.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxycodone And Acetaminophen?
- 110 other product NDCs are listed under this name. See all Oxycodone 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 Oxycodone 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) |
|---|---|---|---|---|---|
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-898 | 60760-0898-3060760-0898-60 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-899 | 60760-0899-3060760-0899-6060760-0899-90 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-897 | 60760-0897-3060760-0897-60 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Direct_Rx | 72189-368 | 72189-0368-3072189-0368-6072189-0368-72+1 more |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | American Health Packaging | 60687-642 | 60687-0642-01 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-668 | 70010-0668-0170010-0668-05 |
| Oxycodone and Acetaminophen | Acetaminophen 325 mg/1; Oxycodone hydrochloride 2.5 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-667 | 70010-0667-0170010-0667-05 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-669 | 70010-0669-0170010-0669-05 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-670 | 70010-0670-0170010-0670-05 |
| Oxycodone And Acetaminophen | Acetaminophen 325 mg/1; Oxycodone hydrochloride 7.5 mg/1 | TabletOral | DIRECT RX | 72189-256 | 72189-0256-3072189-0256-6072189-0256-72 |
Other NDCs under ANDA 207419
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 |
|---|---|---|---|---|
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Direct_Rx | 61919-871 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Proficient Rx LP | 71205-486 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-113 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-114 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-115 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-116 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1953 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5054 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8834 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-193 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-191 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-192 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-194 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-949 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-948 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-950 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-951 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2041 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8888 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Direct_Rx | 72189-368 |
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