What is NDC 43602-004?

43602-004 is the product NDC for Hydromorphone Hydrochloride, Hydromorphone hydrochloride 8 mg/1 tablet, listed with the FDA by Ascent Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Ascent Pharmaceuticals Inc, NDC labeler code 43602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hydromorphone Hydrochloride?

64 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydromorphone Hydrochloride NDC 43602-004

NDC codes

FDA NDC Directory

Product NDC (as listed)43602-004Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43602-0004Add 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	Copy
43602-004-05	4360200040543602000405	500 TABLET in 1 BOTTLE (43602-004-05)Marketed from Jan 24, 2018
43602-004-30	4360200043043602000430	30 TABLET in 1 BOTTLE (43602-004-30)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 — 8 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Ascent Pharmaceuticals IncNDC labeler code 43602
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210506
Marketing start: Jan 24, 2018
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 43602-004_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

N443602000405 followed by a unit qualifier and the quantity

Package 43602-0004-05. 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)

About NDC 43602-004

What is NDC 43602-004?: 43602-004 is the product NDC for Hydromorphone Hydrochloride, Hydromorphone hydrochloride 8 mg/1 tablet, listed with the FDA by Ascent Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hydromorphone Hydrochloride.
What is the active ingredient?: Hydromorphone hydrochloride.
Who is the labeler?: Ascent Pharmaceuticals Inc, NDC labeler code 43602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydromorphone Hydrochloride?: 64 other product NDCs are listed under this name. See all Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 4 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-998	60760-0998-60
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6254	00641-6254-01
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6169	00641-6169-10
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6170	00641-6170-10
Hydromorphone Hydrochloride	Hydromorphone hydrochloride .5 mg/.5mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6206	00641-6206-10
Hydromorphone Hydrochloride	Hydromorphone hydrochloride .2 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6259	00641-6259-10
Hydromorphone Hydrochloride	Hydromorphone hydrochloride .25 mg/.5mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Hospira, Inc.	0409-1805	00409-1805-01
Hydromorphone Hydrochloride	Hydromorphone hydrochloride .5 mg/.5mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Hospira, Inc.	0409-4264	00409-4264-01
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 5 mg/5mL	SolutionOral	American Health Packaging	60687-566	60687-0566-86
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/1	TabletOral	American Health Packaging	60687-579	60687-0579-01

All 65 Hydromorphone Hydrochloride NDCs

Other NDCs under ANDA 210506

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

FDA NDC Directory listings under ANDA 210506
Product	Strength	Form · route	Labeler	Product NDC
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/1	TabletOral	Ascent Pharmaceuticals Inc	43602-002
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 4 mg/1	TabletOral	Ascent Pharmaceuticals Inc	43602-003