Prescription drug · ANDA

Oxycodone Hydrochloride NDC 42858-001

Oxycodone hydrochloride 5 mg/1 · Tablet · Oral · Rhodes Pharmaceuticals LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)42858-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42858-0001Add 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
42858-001-0142858000101100 TABLET in 1 BOTTLE, PLASTIC (42858-001-01)Marketed from Sep 8, 2014
42858-001-104285800011010 BLISTER PACK in 1 CARTON (42858-001-10) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 8, 2014

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)
Oxycodone Hydrochloride
Generic name (nonproprietary)
oxycodone hydrochloride
Active ingredients
Oxycodone hydrochloride — 5 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091490
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 42858-001_d95a9c89-1435-4594-be8b-e19e23d07c0aSPL ID d95a9c89-1435-4594-be8b-e19e23d07c0aSPL set ID a5162476-1217-41c0-bc7e-0a0f123f069fRxCUI 1049611, 1049618, 1049621, 1049683, 1049686UNII C1ENJ2TE6CUPC 0342858002011, 0342858005012, 0342858004015, 0342858001014, 0342858003018
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

N442858000101 followed by a unit qualifier and the quantity

Package 42858-0001-01. 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)

Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone hydrochloride tablets are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) 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, reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091490

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

FDA NDC Directory listings under ANDA 091490
ProductStrengthForm · routeLabelerProduct NDC
Oxycodone HydrochlorideOxycodone hydrochloride 15 mg/1TabletOralBryant Ranch Prepack71335-1413
Oxycodone HydrochlorideOxycodone hydrochloride 30 mg/1TabletOralBryant Ranch Prepack71335-1414
Oxycodone HydrochlorideOxycodone hydrochloride 5 mg/1TabletOralBryant Ranch Prepack71335-1421
Oxycodone HydrochlorideOxycodone hydrochloride 10 mg/1TabletOralBryant Ranch Prepack71335-1422
Oxycodone HydrochlorideOxycodone hydrochloride 15 mg/1TabletOralBryant Ranch Prepack63629-8526
Oxycodone HydrochlorideOxycodone hydrochloride 10 mg/1TabletOralAsclemed USA, Inc.76420-757
Oxycodone HydrochlorideOxycodone hydrochloride 15 mg/1TabletOralAsclemed USA, Inc.76420-758
Oxycodone HydrochlorideOxycodone hydrochloride 20 mg/1TabletOralAsclemed USA, Inc.76420-761
Oxycodone HydrochlorideOxycodone hydrochloride 30 mg/1TabletOralAsclemed USA, Inc.76420-762
Oxycodone HydrochlorideOxycodone hydrochloride 30 mg/1TabletOralRhodes Pharmaceuticals LLC42858-005
Oxycodone HydrochlorideOxycodone hydrochloride 10 mg/1TabletOralRhodes Pharmaceuticals LLC42858-002
Oxycodone HydrochlorideOxycodone hydrochloride 15 mg/1TabletOralRhodes Pharmaceuticals LLC42858-003
Oxycodone HydrochlorideOxycodone hydrochloride 20 mg/1TabletOralRhodes Pharmaceuticals LLC42858-004
Oxycodone HydrochlorideOxycodone hydrochloride 5 mg/1TabletOralAsclemed USA, Inc.76420-897
Oxycodone HydrochlorideOxycodone hydrochloride 30 mg/1TabletOralBryant Ranch Prepack72162-1337
Oxycodone HydrochlorideOxycodone hydrochloride 5 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2899
Oxycodone HydrochlorideOxycodone hydrochloride 5 mg/1TabletOralBryant Ranch Prepack72162-1334
Oxycodone HydrochlorideOxycodone hydrochloride 10 mg/1TabletOralBryant Ranch Prepack72162-1335
Oxycodone HydrochlorideOxycodone hydrochloride 15 mg/1TabletOralBryant Ranch Prepack72162-1336

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in
Oxycodone Hydrochloride NDC 42858-001 | Med-Code