NDC codes

FDA NDC Directory
Product NDC (as listed)42806-113Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42806-0113Add 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
42806-113-014280601130142806011301100 TABLET in 1 BOTTLE (42806-113-01)Marketed from Apr 2, 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

Generic name (nonproprietary)
hydrocodone bitartrate and acetaminophen
Active ingredients
Acetaminophen — 325 mg/1Hydrocodone bitartrate — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Epic Pharma, LLCNDC labeler code 42806
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203863
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 42806-113_b3500a38-9dd0-4950-94f5-337c8f064e94SPL ID b3500a38-9dd0-4950-94f5-337c8f064e94SPL set ID 5179d4ab-6d57-4613-84fc-de3f6edd6a53RxCUI 856999, 857002, 857005UNII 362O9ITL9D, NO70W886KKUPC 0342806113011, 0342806111017
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

N442806011301 followed by a unit qualifier and the quantity

Package 42806-0113-01. 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 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)

About NDC 42806-113

What is NDC 42806-113?
42806-113 is the product NDC for Hydrocodone Bitartrate and Acetaminophen, Acetaminophen 325 mg/1; Hydrocodone bitartrate 10 mg/1 tablet, listed with the FDA by Epic Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hydrocodone Bitartrate and Acetaminophen.
What is the active ingredient?
Acetaminophen, Hydrocodone bitartrate.
Who is the labeler?
Epic Pharma, LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydrocodone Bitartrate and Acetaminophen?
202 other product NDCs are listed under this name. See all Hydrocodone Bitartrate and Acetaminophen 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 Hydrocodone Bitartrate and Acetaminophen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-87360760-0873-3060760-0873-60
Hydrocodone Bitartrate and AcetaminophenAcetaminophen 325 mg/1; Hydrocodone bitartrate 10 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-87260760-0872-3060760-0872-60
hydrocodone bitartrate and acetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralStrides Pharma Science Limited64380-44064380-0440-01
hydrocodone bitartrate and acetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralStrides Pharma Science Limited64380-44164380-0441-01
hydrocodone bitartrate and acetaminophenHydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1TabletOralStrides Pharma Science Limited64380-44264380-0442-01
hydrocodone bitartrate and acetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralProficient Rx LP82804-30682804-0306-12
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 2.5 mg/1; Acetaminophen 325 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-94031722-0940-01
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-94231722-0942-0131722-0942-05
Hydrocodone Bitartrate And AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-87060760-0870-3060760-0870-60
Hydrocodone Bitartrate And AcetaminophenHydrocodone bitartrate 10 mg/15mL; Acetaminophen 300 mg/15mLLiquidOralHikma Pharmaceuticals USA Inc.0054-084300054-0843-63

All 203 Hydrocodone Bitartrate and Acetaminophen NDCs

Other NDCs under ANDA 203863

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

FDA NDC Directory listings under ANDA 203863
ProductStrengthForm · routeLabelerProduct NDC
Hydrocodone Bitartrate and AcetaminophenAcetaminophen 325 mg/1; Hydrocodone bitartrate 5 mg/1TabletOralEpic Pharma, LLC42806-111
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralEpic Pharma, LLC42806-112

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