Prescription drug · ANDA
Hydromorphone Hydrochloride NDC 71335-0723
Hydromorphone hydrochloride 4 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0723-0 | 71335072300 | 90 TABLET in 1 BOTTLE (71335-0723-0)Marketed from Apr 16, 2018 | |
| 71335-0723-1 | 71335072301 | 30 TABLET in 1 BOTTLE (71335-0723-1)Marketed from Mar 8, 2018 | |
| 71335-0723-2 | 71335072302 | 180 TABLET in 1 BOTTLE (71335-0723-2)Marketed from Aug 9, 2024 | |
| 71335-0723-3 | 71335072303 | 120 TABLET in 1 BOTTLE (71335-0723-3)Marketed from Aug 9, 2024 | |
| 71335-0723-4 | 71335072304 | 20 TABLET in 1 BOTTLE (71335-0723-4)Marketed from Aug 9, 2024 | |
| 71335-0723-5 | 71335072305 | 25 TABLET in 1 BOTTLE (71335-0723-5)Marketed from Aug 9, 2024 | |
| 71335-0723-6 | 71335072306 | 100 TABLET in 1 BOTTLE (71335-0723-6)Marketed from Aug 9, 2024 | |
| 71335-0723-7 | 71335072307 | 60 TABLET in 1 BOTTLE (71335-0723-7)Marketed from Apr 16, 2018 | |
| 71335-0723-8 | 71335072308 | 56 TABLET in 1 BOTTLE (71335-0723-8)Marketed from Aug 9, 2024 | |
| 71335-0723-9 | 71335072309 | 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 Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205814
- Marketing start
- Listing expires
- 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
N471335072300followed by a unit qualifier and the quantityPackage 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 205814
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 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 |