What is NDC 69848-588?

69848-588 is the product NDC for Aacetaminophen and Ibuprofen, Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 tablet, listed with the FDA by GRANULES USA, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Aacetaminophen and Ibuprofen (Acetaminophen and Ibuprofen).

GRANULES USA, INC., NDC labeler code 69848. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Aacetaminophen and Ibuprofen?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Aacetaminophen and Ibuprofen NDC 69848-588

NDC codes

FDA NDC Directory

Product NDC (as listed)69848-588Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69848-0588Add 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
69848-588-72	6984805887269848058872	72 TABLET in 1 BOTTLE (69848-588-72)Marketed from Dec 10, 2024

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): Aacetaminophen and Ibuprofen
Generic name (nonproprietary): acetaminophen and ibuprofen
Active ingredients: Acetaminophen — 250 mg/1Ibuprofen — 125 mg/1
Dosage form: Tablet
Route: Oral
Labeler: GRANULES USA, INC.NDC labeler code 69848
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216592
Marketing start: Dec 10, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 69848-588_2a306431-7813-346e-e063-6294a90aca46SPL ID 2a306431-7813-346e-e063-6294a90aca46SPL set ID 1dd90684-6505-8e07-e063-6394a90afdf4RxCUI 2387532UNII 362O9ITL9D, WK2XYI10QM
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

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

N469848058872 followed by a unit qualifier and the quantity

Package 69848-0588-72. 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 Dec 26, 2024.

Indications (excerpt from the label)

Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69848-588

What is NDC 69848-588?: 69848-588 is the product NDC for Aacetaminophen and Ibuprofen, Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 tablet, listed with the FDA by GRANULES USA, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Aacetaminophen and Ibuprofen (Acetaminophen and Ibuprofen).
What is the active ingredient?: Acetaminophen, Ibuprofen.
Who is the labeler?: GRANULES USA, INC., NDC labeler code 69848. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Aacetaminophen and Ibuprofen?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 216592

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

FDA NDC Directory listings under ANDA 216592
Product	Strength	Form · route	Labeler	Product NDC
Period Pills by Biikayacetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	TabletOral	Kai Squared	85576-101
Acetaminophen and Ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	TabletOral	RUGBY LABORATORIES	0536-1376
Acetaminophen and Ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	TabletOral	Family Dollar	55319-139
Acetaminophen and Ibuprofen (NSAID)	Ibuprofen 125 mg/1; Acetaminophen 250 mg/1	TabletOral	Wal-Mart Stores Inc.	79903-931
Acetaminophen and Ibuprofen	Ibuprofen 125 mg/1; Acetaminophen 250 mg/1	TabletOral	CVS	51316-131
Acetaminophen and Ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	TabletOral	CVS	51316-132
Acetaminophen and Ibuprofen	Ibuprofen 125 mg/1; Acetaminophen 250 mg/1	TabletOral	WAL-MART STORES INC.	79903-244
Acetaminophen and Ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-131
Acetaminophen and Ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	TabletOral	WALGREENS	0363-9131
Acetaminophen and Ibuprofen Back Painacetaminophen and ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-213
Acetaminophen and Ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	TabletOral	LEADER/ Cardinal Health 110, Inc.	70000-0622
Acetaminophen and Ibuprofen (NSAID)	Ibuprofen 125 mg/1; Acetaminophen 250 mg/1	TabletOral	RITE AID	11822-1131
Dual Action Pain Relief	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	CapsuleOral	Allegiant Health	69168-462
Acetaminophen and Ibuprofen (NSAID)	Ibuprofen 125 mg/1; Acetaminophen 250 mg/1	TabletOral	RETAIL BUSINESS SERVICES,LLC	72476-131
Acetaminophen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	TabletOral	RAONBIO CORP	70038-131

Aacetaminophen and Ibuprofen (Acetaminophen and ibuprofen) NDC 69848-588