Hydrocodone Bitartrate and Acetaminophen NDC 63629-2469

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-2469Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-2469Add 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 NDC	11-digit (billing)	Package	Copy
63629-2469-1	63629246901	100 TABLET in 1 BOTTLE (63629-2469-1)Marketed from Apr 12, 2016

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 — 7.5 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202991
Marketing start: Apr 12, 2016
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 63629-2469_b29b6c65-abd2-4850-a94d-377016431198SPL ID b29b6c65-abd2-4850-a94d-377016431198SPL set ID 025eb0f7-d002-4ce0-87b8-71461ab18356UNII 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

N463629246901 followed by a unit qualifier and the quantity

Package 63629-2469-01. 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 Aug 8, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablets, USP 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, which can occur at any dosage or duration [see WARNINGS ] , reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia Hydrocodone b…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202991

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

FDA NDC Directory listings under ANDA 202991
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-8499
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	72162-1342
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1417
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1418
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1419
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1811
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	76420-257
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1444
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1470
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	72162-2271
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1557
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Rhodes Pharmaceuticals LLC	42858-202
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Rhodes Pharmaceuticals LLC	42858-201
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Rhodes Pharmaceuticals LLC	42858-203
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-2468
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-2470
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-2471
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	76420-133
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	72162-1341
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	76420-215