Prescription drug · ANDA
Meclizine Hydrochloride NDC 62135-954
Meclizine hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-954-60 | 62135095460 | 60 TABLET, FILM COATED in 1 BOTTLE (62135-954-60)Marketed from Mar 4, 2025 |
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)
- Meclizine Hydrochloride
- Generic name (nonproprietary)
- meclizine hydrochloride
- Active ingredients
- Meclizine hydrochloride — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203003
- Marketing start
- Listing expires
- Other FDA classes
- Emesis Suppression (Physiologic effect)
- Identifiers
- Product ID 62135-954_30511729-d20f-8726-e063-6394a90a6053SPL ID 30511729-d20f-8726-e063-6394a90a6053SPL set ID 87d4c6d8-9218-48c2-9163-615a32449f11RxCUI 995624, 995666, 995686UNII HDP7W44CIOUPC 0362135954604, 0362135952907, 0362135953904
- Pharmacologic class
- Antiemetic
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
N462135095460followed by a unit qualifier and the quantityPackage 62135-0954-60. 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)
Meclizine hydrochloride tablet is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablet is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203003
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 |
|---|---|---|---|---|
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-952 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-953 |