What is NDC 71335-0723?

71335-0723 is the product NDC for Hydromorphone Hydrochloride, Hydromorphone hydrochloride 4 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-0723

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0723Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0723Add 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
71335-0723-0	7133507230071335072300	90 TABLET in 1 BOTTLE (71335-0723-0)Marketed from Apr 16, 2018
71335-0723-1	7133507230171335072301	30 TABLET in 1 BOTTLE (71335-0723-1)Marketed from Mar 8, 2018
71335-0723-2	7133507230271335072302	180 TABLET in 1 BOTTLE (71335-0723-2)Marketed from Aug 9, 2024
71335-0723-3	7133507230371335072303	120 TABLET in 1 BOTTLE (71335-0723-3)Marketed from Aug 9, 2024
71335-0723-4	7133507230471335072304	20 TABLET in 1 BOTTLE (71335-0723-4)Marketed from Aug 9, 2024
71335-0723-5	7133507230571335072305	25 TABLET in 1 BOTTLE (71335-0723-5)Marketed from Aug 9, 2024
71335-0723-6	7133507230671335072306	100 TABLET in 1 BOTTLE (71335-0723-6)Marketed from Aug 9, 2024
71335-0723-7	7133507230771335072307	60 TABLET in 1 BOTTLE (71335-0723-7)Marketed from Apr 16, 2018
71335-0723-8	7133507230871335072308	56 TABLET in 1 BOTTLE (71335-0723-8)Marketed from Aug 9, 2024
71335-0723-9	7133507230971335072309	140 TABLET in 1 BOTTLE (71335-0723-9)Marketed from Aug 9, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 4 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205814
Marketing start: May 17, 2016
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 71335-0723_dd7057dd-4448-4f11-8c2d-6a1bfe0e1f50SPL ID dd7057dd-4448-4f11-8c2d-6a1bfe0e1f50SPL set ID 29765ff0-3b1d-47da-953e-28bf0e6a56efRxCUI 897702UNII L960UP2KRW
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

N471335072300 followed by a unit qualifier and the quantity

Package 71335-0723-00. 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 Aug 9, 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,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0723

What is NDC 71335-0723?: 71335-0723 is the product NDC for Hydromorphone Hydrochloride, Hydromorphone hydrochloride 4 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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 205814

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

FDA NDC Directory listings under ANDA 205814
Product	Strength	Form · route	Labeler	Product NDC
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/1	TabletOral	Aurolife Pharma, LLC	13107-107
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 4 mg/1	TabletOral	Aurolife Pharma, LLC	13107-108
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 8 mg/1	TabletOral	Aurolife Pharma, LLC	13107-109