Hydromorphone Hydrochloride NDC 43602-002

NDC codes

FDA NDC Directory

Product NDC (as listed)43602-002Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43602-0002Add 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
43602-002-05	43602000205	500 TABLET in 1 BOTTLE (43602-002-05)Marketed from Jan 24, 2018
43602-002-30	43602000230	30 TABLET in 1 BOTTLE (43602-002-30)Marketed from Jan 24, 2018

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 — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Ascent Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210506
Marketing start: Jan 24, 2018
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 43602-002_b492adee-8ae4-476e-8047-c13fb2136b58SPL ID b492adee-8ae4-476e-8047-c13fb2136b58SPL set ID 4de15afe-d676-4faa-a34d-9b9cb20dbf54RxCUI 897696, 897702, 897710UNII L960UP2KRWUPC 0343602002059, 0343602004053, 0343602003056, 0343602002301
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

N443602000205 followed by a unit qualifier and the quantity

Package 43602-0002-05. 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 Sep 4, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Hydromorphone Hydrochloride 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 and Precautions (5.2)], reserve Hydromorphone Hydrochloride Tablets 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 Tablets contain hydromorphone, a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)