Prescription drug · ANDA

Hydrocodone Bitartrate and Acetaminophen NDC 42858-203

Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Rhodes Pharmaceuticals LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)42858-203Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42858-0203Add 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
42858-203-0142858020301100 TABLET in 1 BOTTLE (42858-203-01)Marketed from Apr 12, 2016
42858-203-1042858020310100 BLISTER PACK in 1 BOX, UNIT-DOSE (42858-203-10) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 12, 2016
42858-203-5042858020350500 TABLET in 1 BOTTLE (42858-203-50)Marketed from Apr 12, 2016
42858-203-90428580203901000 TABLET in 1 BOTTLE (42858-203-90)Marketed from Apr 12, 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 — 10 mg/1Acetaminophen — 325 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202991
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 42858-203_73b8637b-1fca-42a5-b359-3c8f67771ffeSPL ID 73b8637b-1fca-42a5-b359-3c8f67771ffeSPL set ID 1f9c1adc-f84f-43de-af5c-d93703aba7f8RxCUI 856999, 857002, 857005UNII NO70W886KK, 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

N442858020301 followed by a unit qualifier and the quantity

Package 42858-0203-01. 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 Hydrocodone Bitartrate and Acetaminophen Tablets, USP 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, [see WARNINGS ] , reserve opioid analgesics, including hydrocodone bitartrate and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202991

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

FDA NDC Directory listings under ANDA 202991
ProductStrengthForm · routeLabelerProduct NDC
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-8499
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack72162-1342
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-1417
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-1418
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-1419
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-1811
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralAsclemed USA, Inc.76420-257
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-1444
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-1470
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack72162-2271
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-1557
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralRhodes Pharmaceuticals LLC42858-202
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralRhodes Pharmaceuticals LLC42858-201
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2469
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2468
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2470
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2471
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralAsclemed USA, Inc.76420-133
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack72162-1341
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1TabletOralAsclemed USA, Inc.76420-215

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Hydrocodone Bitartrate and Acetaminophen NDC 42858-203 | Med-Code