What is NDC 72189-352?

72189-352 is the product NDC for Hydrocodone APAP, Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Direct_Rx. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Hydrocodone bitartrate, Acetaminophen.

Direct_Rx, NDC labeler code 72189. 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 APAP?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydrocodone APAP NDC 72189-352 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-352Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0352Add 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
72189-352-30	72189035230	30 TABLET in 1 BOTTLE (72189-352-30)Marketed from May 10, 2022
72189-352-60	72189035260	60 TABLET in 1 BOTTLE (72189-352-60)Marketed from May 10, 2022
72189-352-72	72189035272	120 TABLET in 1 BOTTLE (72189-352-72)Marketed from May 10, 2022
72189-352-90	72189035290	90 TABLET in 1 BOTTLE (72189-352-90)Marketed from May 10, 2022

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

Brand name (proprietary): Hydrocodone APAP
Generic name (nonproprietary): hydrocodone apap
Active ingredients: Hydrocodone bitartrate — 7.5 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211487
Marketing start: May 10, 2022
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 72189-352_2cc75c9b-0042-6e35-e063-6394a90adfb5SPL ID 2cc75c9b-0042-6e35-e063-6394a90adfb5SPL set ID deaa53c1-81ed-7497-e053-2995a90a07ccRxCUI 857005UNII 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

N472189035230 followed by a unit qualifier and the quantity

Package 72189-0352-30. 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 Jan 28, 2025.

Indications (excerpt from the label)

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, even at recommended doses [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen tablets, USP 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)

About NDC 72189-352

What is NDC 72189-352?: 72189-352 is the product NDC for Hydrocodone APAP, Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Direct_Rx. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hydrocodone APAP.
What is the active ingredient?: Hydrocodone bitartrate, Acetaminophen.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. 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 APAP?: 4 other product NDCs are listed under this name. See all Hydrocodone APAP 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 APAP NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydrocodone/APAP	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-649	72189-0649-2072189-0649-3072189-0649-60
Hydrocodone/APAP	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-650	72189-0650-3072189-0650-60
Hydrocodone/APAP	Acetaminophen 325 mg/1; Hydrocodone bitartrate 5 mg/1	TabletOral	Direct_Rx	72189-407	72189-0407-3072189-0407-6072189-0407-72+1 more
Hydrocodone/Apap	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-406	72189-0406-3072189-0406-6072189-0406-90

Other NDCs under ANDA 211487

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

FDA NDC Directory listings under ANDA 211487
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-9602
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-110
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 2.5 mg/1; Acetaminophen 325 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-109
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-111
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-112
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-2195
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 2.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-940
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-942
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-202
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 2.5 mg/1; Acetaminophen 325 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-201
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-996
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-203
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-204
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-997
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct Rx	72189-343
Hydrocodone Bitartrate And Acetaminophen	Acetaminophen 325 mg/1; Hydrocodone bitartrate 10 mg/1	TabletOral	DirectRx	72189-348
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-2104
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-2103
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-2105
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-2112

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