What is NDC 13107-004?

13107-004 is the product NDC for Hydrocodone Bitartrate and Ibuprofen, Hydrocodone bitartrate 7.5 mg/1; Ibuprofen 200 mg/1 tablet, film coated, listed with the FDA by Aurolife Pharma, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Hydrocodone bitartrate, Ibuprofen.

Aurolife Pharma, LLC, NDC labeler code 13107. 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 13107-004

NDC codes

FDA NDC Directory

Product NDC (as listed)13107-004Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13107-0004Add 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
13107-004-01	1310700040113107000401	100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01)Marketed from Jun 2, 2016
13107-004-05	1310700040513107000405	500 TABLET, FILM COATED in 1 BOTTLE (13107-004-05)Marketed from Jun 2, 2016
13107-004-11	1310700041113107000411	10 TABLET, FILM COATED in 1 BOTTLE (13107-004-11)Marketed from Jun 2, 2016
13107-004-99	1310700049913107000499	1000 TABLET, FILM COATED in 1 BOTTLE (13107-004-99)Marketed from Jun 2, 2016

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 — 7.5 mg/1Ibuprofen — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurolife Pharma, LLCNDC labeler code 13107
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204575
Marketing start: Jun 2, 2016
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Opioid Agonists (Mechanism)
Identifiers: Product ID 13107-004_ef408ee9-6806-423f-9998-53d81cc71b94SPL ID ef408ee9-6806-423f-9998-53d81cc71b94SPL set ID 470df63a-5c0f-42df-9023-a330a901153eRxCUI 858798UNII NO70W886KK, WK2XYI10QMUPC 0313107004018
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

N413107000401 followed by a unit qualifier and the quantity

Package 13107-0004-01. 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 Dec 23, 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 Ibuprofe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13107-004

What is NDC 13107-004?: 13107-004 is the product NDC for Hydrocodone Bitartrate and Ibuprofen, Hydrocodone bitartrate 7.5 mg/1; Ibuprofen 200 mg/1 tablet, film coated, listed with the FDA by Aurolife Pharma, LLC. It has 4 package NDCs, 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?: Aurolife Pharma, LLC, NDC labeler code 13107. 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 2.5 mg/1; Ibuprofen 200 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-116	53746-0116-01
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