NDC codes

FDA NDC Directory
Product NDC (as listed)63629-2532Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-2532Add 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
63629-2532-1636292532016 PACKET in 1 BOX (63629-2532-1) / 1 SUPPOSITORY in 1 PACKETMarketed from Apr 28, 2021

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 — 3 mg/1
Dosage form
Suppository
Route
Rectal
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 63629-2532_971f9f4c-1e16-40fb-b08f-e5dc1424e2d2SPL ID 971f9f4c-1e16-40fb-b08f-e5dc1424e2d2SPL set ID bec32a94-4b79-4bd4-b000-45e9030d3106RxCUI 897749UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N463629253201 followed by a unit qualifier and the quantity

Package 63629-2532-01. 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 suppositories 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 ( 5.1 )] , reserve hydromorphone hydrochloride suppositories 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 suppositories…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-2532

What is NDC 63629-2532?
63629-2532 is the product NDC for Hydromorphone Hydrochloride, Hydromorphone hydrochloride 3 mg/1 suppository, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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

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