NDC codes

FDA NDC Directory
Product NDC (as listed)0406-0123Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00406-0123Add 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
0406-0123-010040601230100406012301100 TABLET in 1 BOTTLE (0406-0123-01)Marketed from Oct 20, 2000
0406-0123-050040601230500406012305500 TABLET in 1 BOTTLE (0406-0123-05)Marketed from Oct 20, 2000
0406-0123-1000406012310004060123101000 TABLET in 1 BOTTLE (0406-0123-10)Marketed from Oct 20, 2000
0406-0123-2300406012323004060123231 TABLET in 1 BLISTER PACK (0406-0123-23)Marketed from Oct 20, 2000
0406-0123-620040601236200406012362100 TABLET in 1 BLISTER PACK (0406-0123-62)Marketed from Oct 20, 2000

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Hydrocodone bitartrate — 5 mg/1Acetaminophen — 325 mg/1
Dosage form
Tablet
Route
Oral
Labeler
SpecGx LLCNDC labeler code 0406
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 0406-0123_748bcfb4-7b4c-420c-a9c8-c93fd481f3d9SPL ID 748bcfb4-7b4c-420c-a9c8-c93fd481f3d9SPL set ID 73c1059b-0c7d-42ef-9827-f018858fc447RxCUI 856999, 857002, 857005UNII 362O9ITL9D, NO70W886KKUPC 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

N400406012301 followed by a unit qualifier and the quantity

Package 00406-0123-01. 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 0406-0123

What is NDC 0406-0123?
0406-0123 is the product NDC for Hydrocodone Bitartrate And Acetaminophen, Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by SpecGx LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hydrocodone Bitartrate And Acetaminophen.
What is the active ingredient?
Hydrocodone bitartrate, Acetaminophen.
Who is the labeler?
SpecGx LLC, NDC labeler code 0406. 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?
201 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 10 mg/1; Acetaminophen 325 mg/1TabletOralStrides Pharma Science Limited64380-44264380-0442-01
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 5 mg/1; Acetaminophen 325 mg/1TabletOralProficient Rx LP82804-30682804-0306-12
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 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 10 mg/15mL; Acetaminophen 300 mg/15mLLiquidOralHikma Pharmaceuticals USA Inc.0054-084300054-0843-63

All 202 Hydrocodone Bitartrate And Acetaminophen NDCs

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/1TabletOralA-S Medication Solutions50090-1778
Hydrocodone Bitartrate And AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralQuality Care Products, LLC55700-992
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/1TabletOralRedPharm Drug, Inc67296-1890
Hydrocodone Bitartrate And AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralProficient Rx LP82804-116
Hydrocodone/APAPAcetaminophen 325 mg/1; Hydrocodone bitartrate 5 mg/1TabletOralDirect_Rx72189-407

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