Prescription drug · ANDA
Vecamyl (Mecamylamine hydrochloride) NDC 69413-558
Mecamylamine hydrochloride 2.5 mg/1 · Tablet · Oral · Vyera Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69413-558-40 | 6941305584069413055840 | 100 TABLET in 1 BOTTLE (69413-558-40)Marketed from Mar 19, 2013 |
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)
- Vecamyl
- Generic name (nonproprietary)
- mecamylamine hydrochloride
- Active ingredients
- Mecamylamine hydrochloride — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Vyera Pharmaceuticals, LLCNDC labeler code 69413
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204054
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Autonomic Ganglionic Activity (Physiologic effect)
- Identifiers
- Product ID 69413-558_a29db678-f591-44c7-be1c-3ec7ae06bea7SPL ID a29db678-f591-44c7-be1c-3ec7ae06bea7SPL set ID 0774cc48-7287-4093-91d6-9df41a81408aRxCUI 1298874, 1373008UNII 4956DJR58OUPC 0369413558400
- Pharmacologic class
- Autonomic Ganglionic Blocker
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
N469413055840followed by a unit qualifier and the quantityPackage 69413-0558-40. 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 For the management of moderately severe to severe essential hypertension and in uncomplicated cases of malignant hypertension.
Excerpt only. Read the full label for complete information.
About NDC 69413-558
- What is NDC 69413-558?
- 69413-558 is the product NDC for Vecamyl (mecamylamine hydrochloride), Mecamylamine hydrochloride 2.5 mg/1 tablet, listed with the FDA by Vyera Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vecamyl (Mecamylamine Hydrochloride).
- What is the active ingredient?
- Mecamylamine hydrochloride.
- Who is the labeler?
- Vyera Pharmaceuticals, LLC, NDC labeler code 69413. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vecamyl?
- 1 other product NDC are listed under this name. See all Vecamyl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vecamyl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vecamylmecamylamine hydrochloride | Mecamylamine hydrochloride 2.5 mg/1 | TabletOral | TILDE Sciences LLC | 83649-558 | 83649-0558-01 |
Other NDCs under ANDA 204054
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 |
|---|---|---|---|---|
| Vecamylmecamylamine hydrochloride | Mecamylamine hydrochloride 2.5 mg/1 | TabletOral | TILDE Sciences LLC | 83649-558 |