What is NDC 71610-916?

71610-916 is the product NDC for Ibuprofen, Ibuprofen 400 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ibuprofen?

663 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ibuprofen NDC 71610-916 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-916Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0916Add 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
71610-916-60	71610091660	90 TABLET, FILM COATED in 1 BOTTLE (71610-916-60)Marketed from Jun 24, 2025
71610-916-80	71610091680	180 TABLET, FILM COATED in 1 BOTTLE (71610-916-80)Marketed from Jun 24, 2025
71610-916-92	71610091692	270 TABLET, FILM COATED in 1 BOTTLE (71610-916-92)Marketed from Jun 24, 2025

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): Ibuprofen
Generic name (nonproprietary): ibuprofen
Active ingredients: Ibuprofen — 400 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202413
Marketing start: May 23, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 71610-916_388e68ec-5061-e4c0-e063-6394a90a35d4SPL ID 388e68ec-5061-e4c0-e063-6394a90a35d4SPL set ID 388e68dc-1822-f375-e063-6294a90a3d41RxCUI 197805UNII 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

N471610091660 followed by a unit qualifier and the quantity

Package 71610-0916-60. 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 Jun 27, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets in children have not been conducted.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-916

What is NDC 71610-916?: 71610-916 is the product NDC for Ibuprofen, Ibuprofen 400 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ibuprofen.
What is the active ingredient?: Ibuprofen.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ibuprofen?: 663 other product NDCs are listed under this name. See all Ibuprofen 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 Ibuprofen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-737	67877-0737-0167877-0737-0567877-0737-33+1 more
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-738	67877-0738-0167877-0738-0567877-0738-30+3 more
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-739	67877-0739-0167877-0739-0567877-0739-30+4 more
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	GOODSENSE	50804-185	50804-0185-0150804-0185-02
Ibuprofen	Ibuprofen 200 mg/1	Tablet, CoatedOral	Shield Pharmaceuticals Corp	83059-0180	83059-0180-04
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Gobrands, Inc. (Goodnow)	82501-1010	82501-1010-00
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4741	70518-4741-0070518-4741-02
Ibuprofen	Ibuprofen 200 mg/1	Tablet, CoatedOral	P & L Development, LLC	59726-003	59726-0003-50
Ibuprofen	Ibuprofen 200 mg/1	Tablet, Film coatedOral	Amazon.com Services LLC	72288-143	72288-0143-7872288-0143-90
Ibuprofen	Ibuprofen 200 mg/1	TabletOral	NUVICARE LLC	84324-038	84324-0038-01

All 664 Ibuprofen NDCs

Other NDCs under ANDA 202413

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

FDA NDC Directory listings under ANDA 202413
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3966
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-584
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2184
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2184
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3679
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-590
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2196
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4039
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Brisk Pharmaceuticals	73614-201
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-846
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-847
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-848
Ibuprofen	Ibuprofen 300 mg/1	TabletOral	SOLA Pharmaceuticals, LLC	70512-794
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-901
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-902
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1606
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	AiPing Pharmaceutical, Inc.	11788-009
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7788
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7789
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	AiPing Pharmaceutical, Inc.	11788-008

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