What is NDC 53746-116?

53746-116 is the product NDC for Hydrocodone Bitartrate and Ibuprofen, Hydrocodone bitartrate 2.5 mg/1; Ibuprofen 200 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Hydrocodone bitartrate, Ibuprofen.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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 Bitartrate and Ibuprofen?

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 Bitartrate and Ibuprofen NDC 53746-116

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0116Add 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
53746-116-01	53746011601	100 TABLET in 1 BOTTLE (53746-116-01)Marketed from Feb 18, 2010

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 Bitartrate and Ibuprofen
Generic name (nonproprietary): hydrocodone bitartrate and ibuprofen
Active ingredients: Hydrocodone bitartrate — 2.5 mg/1Ibuprofen — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076642
Marketing start: Feb 18, 2010
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Opioid Agonists (Mechanism)
Identifiers: Product ID 53746-116_e109d65b-643b-4c2e-80ad-30c7b3e9c160SPL ID e109d65b-643b-4c2e-80ad-30c7b3e9c160SPL set ID abc33718-4e88-43ea-9ffa-2b04ffc812efRxCUI 858770, 858778, 858798, 859315UNII WK2XYI10QM, NO70W886KKUPC 0353746117014, 0353746145017, 0353746116017, 0353746146014
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug; 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

N453746011601 followed by a unit qualifier and the quantity

Package 53746-0116-01. 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 Nov 21, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation ) . Do not use hydrocodone bitartrate and ibupro…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53746-116

What is NDC 53746-116?: 53746-116 is the product NDC for Hydrocodone Bitartrate and Ibuprofen, Hydrocodone bitartrate 2.5 mg/1; Ibuprofen 200 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hydrocodone Bitartrate and Ibuprofen.
What is the active ingredient?: Hydrocodone bitartrate, Ibuprofen.
Who is the labeler?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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 Bitartrate and Ibuprofen?: 4 other product NDCs are listed under this name. See all Hydrocodone Bitartrate and 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 Hydrocodone Bitartrate and Ibuprofen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydrocodone Bitartrate and Ibuprofen	Hydrocodone bitartrate 7.5 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Aurolife Pharma, LLC	13107-004	13107-0004-0113107-0004-0513107-0004-11+1 more
Hydrocodone Bitartrate and Ibuprofen	Hydrocodone bitartrate 10 mg/1; Ibuprofen 200 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-117	53746-0117-01
Hydrocodone Bitartrate and Ibuprofen	Hydrocodone bitartrate 7.5 mg/1; Ibuprofen 200 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-145	53746-0145-0153746-0145-05
Hydrocodone Bitartrate and Ibuprofen	Hydrocodone bitartrate 5 mg/1; Ibuprofen 200 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-146	53746-0146-01

Other NDCs under ANDA 076642

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

FDA NDC Directory listings under ANDA 076642
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate and Ibuprofen	Hydrocodone bitartrate 10 mg/1; Ibuprofen 200 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-117
Hydrocodone Bitartrate and Ibuprofen	Hydrocodone bitartrate 7.5 mg/1; Ibuprofen 200 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-145
Hydrocodone Bitartrate and Ibuprofen	Hydrocodone bitartrate 5 mg/1; Ibuprofen 200 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-146