Prescription drug · ANDA
Hydralazine Hydrochloride NDC 68788-8087
Hydralazine hydrochloride 100 mg/1 · Tablet · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68788-8087Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8087Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8087-1 | 6878880870168788808701 | 100 TABLET in 1 BOTTLE (68788-8087-1)Marketed from Oct 5, 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)
- Hydralazine Hydrochloride
- Generic name (nonproprietary)
- hydralazine hydrochloride
- Active ingredients
- Hydralazine hydrochloride — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- 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 68788-8087_4dea31eb-3662-41d5-aa2a-292b5a0ae9ddSPL ID 4dea31eb-3662-41d5-aa2a-292b5a0ae9ddSPL set ID 438479d0-ff61-4008-a0fc-1ee44b97cf7fRxCUI 905222UNII 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
N468788808701followed by a unit qualifier and the quantityPackage 68788-8087-01. 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 .
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 68788-8087
- What is NDC 68788-8087?
- 68788-8087 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 100 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals, Inc.. 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?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2551 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 71205-091 |
| 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 |