NDC codes

FDA NDC Directory
Product NDC (as listed)10702-071Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10702-0071Add 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
10702-071-011070200710110702007101100 TABLET in 1 BOTTLE (10702-071-01)Marketed from Feb 11, 2013
10702-071-06107020071061070200710660 TABLET in 1 BOTTLE (10702-071-06)Marketed from Jun 25, 2018

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 — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
KVK-Tech, Inc.NDC labeler code 10702
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203601
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 10702-071_499ffc26-7516-aea3-e063-6394a90a5845SPL ID 499ffc26-7516-aea3-e063-6394a90a5845SPL set ID dcb5b5d2-7d0a-497a-8f1e-3b96fd43320bRxCUI 977939, 977942UNII 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

N410702007101 followed by a unit qualifier and the quantity

Package 10702-0071-01. 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 tablets are indicated for the management of acute 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 and Precautions (5.1)] , reserve opioid analgesics, including oxymorphone hydrochloride for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Limitations of Use (1) Because of the risks of addiction, abuse, misuse, overdose…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 10702-071

What is NDC 10702-071?
10702-071 is the product NDC for Oxymorphone Hydrochloride, Oxymorphone hydrochloride 10 mg/1 tablet, listed with the FDA by KVK-Tech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Oxymorphone Hydrochloride.
What is the active ingredient?
Oxymorphone hydrochloride.
Who is the labeler?
KVK-Tech, Inc., NDC labeler code 10702. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oxymorphone Hydrochloride?
26 other product NDCs are listed under this name. See all Oxymorphone Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Oxymorphone Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Oxymorphone HydrochlorideOxymorphone hydrochloride 5 mg/1TabletOralXLCare Pharmaceuticals, Inc.72865-13072865-0130-01
Oxymorphone HydrochlorideOxymorphone hydrochloride 10 mg/1TabletOralXLCare Pharmaceuticals, Inc.72865-13172865-0131-01
Oxymorphone HydrochlorideOxymorphone hydrochloride 5 mg/1TabletOralEpic Pharma, LLC42806-33042806-0330-01
Oxymorphone HydrochlorideOxymorphone hydrochloride 10 mg/1TabletOralEpic Pharma, LLC42806-33142806-0331-01
Oxymorphone HydrochlorideOxymorphone hydrochloride 5 mg/1TabletOralCamber Pharmaceuticals, Inc31722-92931722-0929-01
Oxymorphone HydrochlorideOxymorphone hydrochloride 10 mg/1TabletOralCamber Pharmaceuticals, Inc31722-93031722-0930-01
Oxymorphone HydrochlorideOxymorphone hydrochloride 5 mg/1TabletOralBryant Ranch Prepack63629-192663629-1926-01
Oxymorphone HydrochlorideOxymorphone hydrochloride 5 mg/1TabletOralAurolife Pharma, LLC13107-10313107-0103-0113107-0103-3013107-0103-99
Oxymorphone HydrochlorideOxymorphone hydrochloride 10 mg/1TabletOralAurolife Pharma, LLC13107-10413107-0104-0113107-0104-3013107-0104-99
Oxymorphone HydrochlorideOxymorphone hydrochloride 5 mg/1TabletOralKVK-Tech, Inc.10702-07010702-0070-0110702-0070-06

All 27 Oxymorphone Hydrochloride NDCs

Other NDCs under ANDA 203601

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

FDA NDC Directory listings under ANDA 203601
ProductStrengthForm · routeLabelerProduct NDC
Oxymorphone HydrochlorideOxymorphone hydrochloride 5 mg/1TabletOralKVK-Tech, Inc.10702-070

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