NDC codes

FDA NDC Directory
Product NDC (as listed)67296-1414Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67296-1414Add 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 NDC11-digit (billing)PackageCopy
67296-1414-1672961414016729614140110 TABLET in 1 BOTTLE (67296-1414-1)Marketed from Dec 23, 2004

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 — 2 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Redpharm DrugNDC labeler code 67296
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076855
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 67296-1414_59d88829-80f2-2cac-e063-6294a90a9346SPL ID 59d88829-80f2-2cac-e063-6294a90a9346SPL set ID 59d88866-e1ba-9d97-e063-6394a90a7b27RxCUI 897696UNII L960UP2KRWUPC 0031100000010
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

N467296141401 followed by a unit qualifier and the quantity

Package 67296-1414-01. 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 . 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.2 )] , reserve opioid analgesics, including hydromorphone hydrochloride tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hydromorphone hydrochloride tablets contain hydromorphone, an opioid agon…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67296-1414

What is NDC 67296-1414?
67296-1414 is the product NDC for Hydromorphone Hydrochloride, Hydromorphone hydrochloride 2 mg/1 tablet, listed with the FDA by Redpharm Drug. It has 1 package NDC, 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?
Redpharm Drug, NDC labeler code 67296. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hydromorphone HydrochlorideHydromorphone hydrochloride 4 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-99860760-0998-60
Hydromorphone HydrochlorideHydromorphone hydrochloride 2 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousHikma Pharmaceuticals USA Inc.0641-625400641-6254-01
Hydromorphone HydrochlorideHydromorphone hydrochloride 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousHikma Pharmaceuticals USA Inc.0641-616900641-6169-10
Hydromorphone HydrochlorideHydromorphone hydrochloride 2 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousHikma Pharmaceuticals USA Inc.0641-617000641-6170-10
Hydromorphone HydrochlorideHydromorphone hydrochloride .5 mg/.5mLInjectionIntramuscular, Intravenous, SubcutaneousHikma Pharmaceuticals USA Inc.0641-620600641-6206-10
Hydromorphone HydrochlorideHydromorphone hydrochloride .2 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousHikma Pharmaceuticals USA Inc.0641-625900641-6259-10
Hydromorphone HydrochlorideHydromorphone hydrochloride .25 mg/.5mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousHospira, Inc.0409-180500409-1805-01
Hydromorphone HydrochlorideHydromorphone hydrochloride .5 mg/.5mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousHospira, Inc.0409-426400409-4264-01
Hydromorphone HydrochlorideHydromorphone hydrochloride 5 mg/5mLSolutionOralAmerican Health Packaging60687-56660687-0566-86
Hydromorphone HydrochlorideHydromorphone hydrochloride 2 mg/1TabletOralAmerican Health Packaging60687-57960687-0579-01

All 65 Hydromorphone Hydrochloride NDCs

Other NDCs under ANDA 076855

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

FDA NDC Directory listings under ANDA 076855
ProductStrengthForm · routeLabelerProduct NDC
Hydromorphone HydrochlorideHydromorphone hydrochloride 2 mg/1TabletOralSpecGx LLC0406-3243
Hydromorphone HydrochlorideHydromorphone hydrochloride 4 mg/1TabletOralSpecGx LLC0406-3244
Hydromorphone HydrochlorideHydromorphone hydrochloride 8 mg/1TabletOralSpecGx LLC0406-3249
Hydromorphone HydrochlorideHydromorphone hydrochloride 2 mg/1TabletOralAmerican Health Packaging60687-579
Hydromorphone HydrochlorideHydromorphone hydrochloride 4 mg/1TabletOralAmerican Health Packaging60687-590

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