NDC codes

FDA NDC Directory
Product NDC (as listed)10702-194Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10702-0194Add 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
10702-194-011070201940110702019401100 TABLET in 1 BOTTLE (10702-194-01)Marketed from Jun 22, 2017
10702-194-03107020194031070201940330 TABLET in 1 BOTTLE (10702-194-03)Marketed from Jun 22, 2017
10702-194-1010702019410107020194101000 TABLET in 1 BOTTLE (10702-194-10)Marketed from Jun 22, 2017
10702-194-501070201945010702019450500 TABLET in 1 BOTTLE (10702-194-50)Marketed from Jun 22, 2017

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
Hydrocodone bitartrate — 10 mg/1Acetaminophen — 300 mg/1
Dosage form
Tablet
Route
Oral
Labeler
KVK-Tech, Inc.NDC labeler code 10702
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209036
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 10702-194_4a169a07-a8cd-ada4-e063-6394a90ac7d2SPL ID 4a169a07-a8cd-ada4-e063-6394a90ac7d2SPL set ID f1063950-b302-4898-81c2-b1626c9c16efRxCUI 856980, 856987, 856992, 856999, 857002, 857005UNII 362O9ITL9D, NO70W886KK
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

N410702019401 followed by a unit qualifier and the quantity

Package 10702-0194-01. 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 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 10702-194

What is NDC 10702-194?
10702-194 is the product NDC for Hydrocodone Bitartrate and Acetaminophen, Hydrocodone bitartrate 10 mg/1; Acetaminophen 300 mg/1 tablet, listed with the FDA by KVK-Tech, Inc.. It has 4 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?
KVK-Tech, Inc., NDC labeler code 10702. 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 209036

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

FDA NDC Directory listings under ANDA 209036
ProductStrengthForm · routeLabelerProduct NDC
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 300 mg/1TabletOralKVK-Tech, Inc.10702-192
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 300 mg/1TabletOralKVK-Tech, Inc.10702-193

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