NDC codes

FDA NDC Directory
Product NDC (as listed)67296-1890Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67296-1890Add 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
67296-1890-26729618900220 TABLET in 1 BOTTLE (67296-1890-2)Marketed from Oct 20, 2000
67296-1890-36729618900330 TABLET in 1 BOTTLE (67296-1890-3)Marketed from Oct 20, 2000
67296-1890-76729618900715 TABLET in 1 BOTTLE (67296-1890-7)Marketed from Oct 20, 2000
67296-1890-86729618900812 TABLET in 1 BOTTLE (67296-1890-8)Marketed from Oct 20, 2000

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 5 mg/1Acetaminophen — 325 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040409
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 67296-1890_408adf9c-b0cb-b42e-e063-6294a90ae1a1SPL ID 408adf9c-b0cb-b42e-e063-6294a90ae1a1SPL set ID fa1b7586-fb26-5e37-e053-6394a90aa92dRxCUI 857002UNII NO70W886KK, 362O9ITL9DUPC 0304060124011, 0304060125018, 0304060123014
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

N467296189002 followed by a unit qualifier and the quantity

Package 67296-1890-02. 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, and misuse, with opioids, even at recommended doses ( see WARNINGS ), reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040409

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

FDA NDC Directory listings under ANDA 040409
ProductStrengthForm · routeLabelerProduct NDC
Hydrocodone Bitartrate And AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralProficient Rx LP82804-116
Hydrocodone Bitartrate And AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralA-S Medication Solutions50090-1778
Hydrocodone/APAPAcetaminophen 325 mg/1; Hydrocodone bitartrate 5 mg/1TabletOralDirect_Rx72189-407
Hydrocodone Bitartrate And AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralGolden State Medical Supply, Inc.60429-590
Hydrocodone Bitartrate And AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-870
Hydrocodone Bitartrate And AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralSpecGx LLC0406-0123
Hydrocodone Bitartrate And AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralQuality Care Products, LLC55700-992

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