Hydromorphone Hydrochloride NDC 43602-001

NDC codes

FDA NDC Directory

Product NDC (as listed)43602-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43602-0001Add 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
43602-001-47	43602000147	473 mL in 1 BOTTLE (43602-001-47)Marketed from May 4, 2019

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): Hydromorphone Hydrochloride
Generic name (nonproprietary): hydromorphone hydrochloride
Active ingredients: Hydromorphone hydrochloride — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Ascent Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210176
Marketing start: May 4, 2019
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 43602-001_c5abd799-51be-4368-b788-b6b6c30b90afSPL ID c5abd799-51be-4368-b788-b6b6c30b90afSPL set ID e8fd7b0e-22b9-4f8a-8eb2-41d5031779afRxCUI 897657UNII L960UP2KRWUPC 0343602279475
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

N443602000147 followed by a unit qualifier and the quantity

Package 43602-0001-47. 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 May 3, 2017. This label includes a boxed warning.

Indications (excerpt from the label)

Hydromorphone Hydrochloride Oral Solution 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 and Precautions (5.2)] , reserve Hydromorphone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydromorphone Hydrochloride Oral Solution conta…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)