Prescription drug · ANDA

Oxymorphone hydrochloride NDC 64896-696

Oxymorphone hydrochloride 7.5 mg/1 · Tablet, Film coated, Extended release · Oral · Amneal Pharmaceuticals LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)64896-696Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64896-0696Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
64896-696-0164896069601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-01)Marketed from Jan 2, 2013
64896-696-03648960696031000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-03)Marketed from Jan 2, 2013
64896-696-086489606960830 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-08)Marketed from Jan 2, 2013
64896-696-136489606961360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-13)Marketed from Jan 2, 2013

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)
Oxymorphone hydrochloride
Generic name (nonproprietary)
oxymorphone hydrochloride
Active ingredients
Oxymorphone hydrochloride — 7.5 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079087
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 64896-696_4f08b804-ef2d-4c9b-8553-c2bc7fa1fd71SPL ID 4f08b804-ef2d-4c9b-8553-c2bc7fa1fd71SPL set ID 3f4e703a-e398-42fd-8759-e398c79955f1RxCUI 977874, 977894, 977902, 977909, 977915, 977923, 977929UNII 5Y2EI94NBC
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

N464896069601 followed by a unit qualifier and the quantity

Package 64896-0696-01. 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)

Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Usage 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 and Precautions (5.1) ] , reserve opioid analgesics, including Oxymorphone Hydrochloride Extended-Release Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient mana…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079087

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 079087
ProductStrengthForm · routeLabelerProduct NDC
Oxymorphone hydrochlorideOxymorphone hydrochloride 7.5 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1315
Oxymorphone hydrochlorideOxymorphone hydrochloride 15 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1316
Oxymorphone hydrochlorideOxymorphone hydrochloride 30 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1317
Oxymorphone hydrochlorideOxymorphone hydrochloride 5 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1231
Oxymorphone hydrochlorideOxymorphone hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1232
Oxymorphone hydrochlorideOxymorphone hydrochloride 20 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1233
Oxymorphone hydrochlorideOxymorphone hydrochloride 40 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1234
Oxymorphone hydrochlorideOxymorphone hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-697
Oxymorphone hydrochlorideOxymorphone hydrochloride 5 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-695
Oxymorphone hydrochlorideOxymorphone hydrochloride 40 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-701
Oxymorphone hydrochlorideOxymorphone hydrochloride 15 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-698
Oxymorphone hydrochlorideOxymorphone hydrochloride 20 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-699
Oxymorphone hydrochlorideOxymorphone hydrochloride 30 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-700

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Oxymorphone hydrochloride NDC 64896-696 | Med-Code