Prescription drug · NDA AUTHORIZED GENERIC
Hydromorphone Hydrochloride NDC 63629-4284
Hydromorphone hydrochloride 2 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-4284-1 | 6362942840163629428401 | 25 TABLET in 1 BOTTLE (63629-4284-1)Marketed from Jun 21, 2010 | |
| 63629-4284-2 | 6362942840263629428402 | 60 TABLET in 1 BOTTLE (63629-4284-2)Marketed from Aug 23, 2011 | |
| 63629-4284-3 | 6362942840363629428403 | 30 TABLET in 1 BOTTLE (63629-4284-3)Marketed from Oct 22, 2010 | |
| 63629-4284-4 | 6362942840463629428404 | 28 TABLET in 1 BOTTLE (63629-4284-4)Marketed from Nov 12, 2010 | |
| 63629-4284-5 | 6362942840563629428405 | 90 TABLET in 1 BOTTLE (63629-4284-5)Marketed from Jun 11, 2014 | |
| 63629-4284-6 | 6362942840663629428406 | 120 TABLET in 1 BOTTLE (63629-4284-6)Marketed from Jun 25, 2012 | |
| 63629-4284-7 | 6362942840763629428407 | 40 TABLET in 1 BOTTLE (63629-4284-7)Marketed from Jan 27, 2014 | |
| 63629-4284-8 | 6362942840863629428408 | 20 TABLET in 1 BOTTLE (63629-4284-8)Marketed from May 1, 2012 | |
| 63629-4284-9 | 6362942840963629428409 | 10 TABLET in 1 BOTTLE (63629-4284-9)Marketed from Aug 24, 2020 |
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
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 019892
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 63629-4284_f895b5fa-f576-4ee7-9747-ada5688ca1abSPL ID f895b5fa-f576-4ee7-9747-ada5688ca1abSPL set ID 2427814c-f32b-8ac5-99b8-5e886fd2d001RxCUI 897696UNII 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
N463629428401followed by a unit qualifier and the quantityPackage 63629-4284-01. 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 oral solution and hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets contain hydromorphone, an opioid agonist, and are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.2 ) , reserve hydromorphone hydrochloride oral solution or hydromorp…
Excerpt only. Read the full label for complete information.
About NDC 63629-4284
- What is NDC 63629-4284?
- 63629-4284 is the product NDC for Hydromorphone Hydrochloride, Hydromorphone hydrochloride 2 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 9 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 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.
Related NDCs: other Hydromorphone Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under NDA 019892
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 8 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-039 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-998 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 2 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-037 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-038 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9701 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 2 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-122 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-234 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 8 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-303 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 2 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-301 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-302 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 8 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-338 |