Hydrocodone Bitartrate And Acetaminophen NDC 55700-991

NDC codes

FDA NDC Directory

Product NDC (as listed)55700-991Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55700-0991Add 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
55700-991-30	55700099130	30 TABLET in 1 BOTTLE (55700-991-30)Marketed from Dec 27, 2022
55700-991-60	55700099160	60 TABLET in 1 BOTTLE (55700-991-60)Marketed from Dec 27, 2022
55700-991-90	55700099190	90 TABLET in 1 BOTTLE (55700-991-90)Marketed from Dec 27, 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 Bitartrate And Acetaminophen
Generic name (nonproprietary): hydrocodone bitartrate and acetaminophen
Active ingredients: Hydrocodone bitartrate — 10 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Quality Care Products, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040400
Marketing start: Dec 27, 2022
Marketing end: May 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 55700-991_d63ec86d-5a5f-44ab-b335-040f0093cb64SPL ID d63ec86d-5a5f-44ab-b335-040f0093cb64SPL set ID e7d36246-9c80-49b6-ad4b-e38c3fd6d068RxCUI 856999UNII 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

N455700099130 followed by a unit qualifier and the quantity

Package 55700-0991-30. 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 Dec 19, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen tablets 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 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)

Other NDCs under ANDA 040400

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

FDA NDC Directory listings under ANDA 040400
Product	Strength	Form · route	Labeler	Product NDC
Norcohydrocodone/apap	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-399
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-871
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	82804-003
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	SpecGx LLC	0406-0125