Prescription drug · ANDA
Hydralazine Hydrochloride NDC 71205-091
Hydralazine hydrochloride 10 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC DirectoryProduct NDC (as listed)71205-091Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0091Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-091-30 | 7120500913071205009130 | 30 TABLET in 1 BOTTLE (71205-091-30)Marketed from Aug 1, 2018 | |
| 71205-091-60 | 7120500916071205009160 | 60 TABLET in 1 BOTTLE (71205-091-60)Marketed from Aug 1, 2018 | |
| 71205-091-90 | 7120500919071205009190 | 90 TABLET in 1 BOTTLE (71205-091-90)Marketed from Aug 1, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Hydralazine Hydrochloride
- Generic name (nonproprietary)
- hydralazine hydrochloride
- Active ingredients
- Hydralazine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040901
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 71205-091_a6c65fd3-3249-48fc-9196-a756d3d06444SPL ID a6c65fd3-3249-48fc-9196-a756d3d06444SPL set ID 48cf71dd-19dc-4239-9117-ebcf9731a45dRxCUI 905199UNII FD171B778Y
- Pharmacologic class
- Arteriolar Vasodilator
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
N471205009130followed by a unit qualifier and the quantityPackage 71205-0091-30. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE: Essential hypertension, alone or as an adjunct.
Excerpt only. Read the full label for complete information.
About NDC 71205-091
- What is NDC 71205-091?
- 71205-091 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 10 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydralazine Hydrochloride.
- What is the active ingredient?
- Hydralazine hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydralazine Hydrochloride?
- 144 other product NDCs are listed under this name. See all Hydralazine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydralazine 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) |
|---|---|---|---|---|---|
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0287 | 55154-0287-00 |
| HydrALAZINE Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Coupler LLC | 67046-2080 | 67046-2080-03 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | Safecor Health, LLC | 48433-046 | 48433-0046-20 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Safecor Health, LLC | 48433-047 | 48433-0047-20 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Safecor Health, LLC | 48433-048 | 48433-0048-20 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Coupler LLC | 67046-1660 | 67046-1660-03 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | Navinta LLC | 68475-514 | 68475-0514-02 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | Coupler LLC | 67046-1609 | 67046-1609-03 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | Baxter Healthcare Corporation | 43066-041 | 43066-0041-25 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0186 | 55154-0186-00 |
Other NDCs under ANDA 040901
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 |
|---|---|---|---|---|
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7973 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-519 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-520 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-521 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-522 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-0137 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-0139 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6684 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5246 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-1940 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-2055 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5285 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-8087 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2551 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0202 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1589 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1685 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Proficient Rx LP | 82804-197 |