Prescription drug · ANDA

Hydrocodone Bitartrate and Acetaminophen NDC 72162-1279

Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)72162-1279Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-1279Add 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
72162-1279-0721621279001000 TABLET in 1 BOTTLE, PLASTIC (72162-1279-0)Marketed from Oct 6, 2014
72162-1279-172162127901100 TABLET in 1 BOTTLE, PLASTIC (72162-1279-1)Marketed from Oct 6, 2014
72162-1279-572162127905500 TABLET in 1 BOTTLE, PLASTIC (72162-1279-5)Marketed from Oct 6, 2014

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 202214
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 72162-1279_6d166e09-db1f-4e94-9c5a-fe35125de894SPL ID 6d166e09-db1f-4e94-9c5a-fe35125de894SPL set ID a3cbf0c1-b589-4e4a-b355-01bddb7e4955RxCUI 857002UNII 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

N472162127900 followed by a unit qualifier and the quantity

Package 72162-1279-00. 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 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 202214

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

FDA NDC Directory listings under ANDA 202214
ProductStrengthForm · routeLabelerProduct NDC
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-692
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2294
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2292
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2293
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2298
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2295
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2296
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2297
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2299
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-2300
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 300 mg/1TabletOralBryant Ranch Prepack63629-2308
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 300 mg/1TabletOralBryant Ranch Prepack63629-2309
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 10 mg/1; Acetaminophen 300 mg/1TabletOralBryant Ranch Prepack63629-2310
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3685
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-2969
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-2740
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-873
Hydrocodone Bitartrate and AcetaminophenAcetaminophen 325 mg/1; Hydrocodone bitartrate 10 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-872
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-2238
Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1TabletOralCranbury Pharmaceuticals, LLC27808-036

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