Prescription drug · ANDA
Hydralazine Hydrochloride NDC 62135-579
Hydralazine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-579-12 | 6213505791262135057912 | 120 TABLET, FILM COATED in 1 BOTTLE (62135-579-12)Marketed from May 9, 2023 |
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, Film coated
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086242
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 62135-579_459c0193-3a85-878d-e063-6294a90afc31SPL ID 459c0193-3a85-878d-e063-6294a90afc31SPL set ID 0c7f9bd0-6c0a-4521-b77a-3582faa96874RxCUI 905199, 905222, 905225, 905395UNII FD171B778YUPC 0362135580124, 0362135581121, 0362135582128, 0362135579128
- 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
N462135057912followed by a unit qualifier and the quantityPackage 62135-0579-12. 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 62135-579
- What is NDC 62135-579?
- 62135-579 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, 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?
- Chartwell RX, LLC, NDC labeler code 62135. 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?
- 143 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 50 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0187 | 55154-0187-00 |
Other NDCs under ANDA 086242
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 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-392 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-580 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-581 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-582 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-901 |