Over-the-counter drug · OTC MONOGRAPH DRUG
Meclizine (Meclizine hcl 12.5 mg) NDC 80513-427
Meclizine hydrochloride 12.5 mg/1 · Tablet · Oral · Advanced Rx LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)80513-427Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80513-0427Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80513-427-02 | 8051304270280513042702 | 200 TABLET in 1 BOTTLE, PLASTIC (80513-427-02)Marketed from Sep 1, 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
- Generic name (nonproprietary)
- meclizine hcl 12.5 mg
- Active ingredients
- Meclizine hydrochloride — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx LLCNDC labeler code 80513
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 009
- Marketing start
- Listing expires
- Other FDA classes
- Emesis Suppression (Physiologic effect)
- Identifiers
- Product ID 80513-427_3e5a4128-ff9c-6f2b-e063-6394a90a42e6SPL ID 3e5a4128-ff9c-6f2b-e063-6394a90a42e6SPL set ID 032a89f2-17e7-45d2-94a1-cc7a601ebdeeRxCUI 995624UNII HDP7W44CIOUPC 0380513000316
- 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
N480513042702followed by a unit qualifier and the quantityPackage 80513-0427-02. 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)
Uses prevents and treats nausea, vomiting or dizziness associated with motion sickness
Excerpt only. Read the full label for complete information.
About NDC 80513-427
- What is NDC 80513-427?
- 80513-427 is the product NDC for Meclizine (meclizine hcl 12.5 mg), Meclizine hydrochloride 12.5 mg/1 tablet, listed with the FDA by Advanced Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Meclizine (Meclizine HCl 12.5 mg).
- What is the active ingredient?
- Meclizine hydrochloride.
- Who is the labeler?
- Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Meclizine?
- 7 other product NDCs are listed under this name. See all Meclizine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Meclizine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Meclizinemeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | Advanced Rx LLC | 80513-421 | 80513-0421-02 |
| Meclizinemeclizine hcl 12.5 mg | Meclizine hydrochloride 12.5 mg/1 | TabletOral | RUGBY LABORATORIES | 0536-1297 | 00536-1297-0100536-1297-10 |
| Meclizinemeclizine hcl 12.5mg | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Ulai Health LLC | 73057-386 | 73057-0386-0873057-0386-11 |
| Meclizinemeclizine hcl 12.5 mg | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Pharbest Pharmaceuticals, Inc. | 16103-386 | 16103-0386-0816103-0386-11 |
| Meclizinemeclizine hcl 25mg | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | Pharbest Pharmaceuticals, Inc. | 16103-387 | 16103-0387-0816103-0387-11 |
| Meclizinemeclizine hcl 25mg | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | PD-Rx Pharmaceuticals, Inc. | 43063-804 | 43063-0804-0143063-0804-0643063-0804-12+2 more |
| Meclizinemeclizine hcl 25mg | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | Bryant Ranch Prepack | 71335-1215 | 71335-1215-0071335-1215-0171335-1215-02+7 more |
Other NDCs under M 009
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 |
|---|---|---|---|---|
| Airmit Acedimenhydrinate | Dimenhydrinate 25 mg/1 | TabletOral | Sato Pharmaceutical Co., Ltd. | 49873-802 |
| Allergy DyeFree | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Allegiant Health | 69168-409 |
| Bangbrek Bee Venom Wart Corn Callus Removersalicylic acid 17% | Salicylic acid 17 mg/mL | LiquidTopical | Brilliance Trade LLC | 85792-001 |
| Boninemeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | WellSpring Pharmaceutical Corporation | 65197-275 |
| Boninemeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | WellSpring Pharmaceutical Corporation | 65197-296 |
| Boninemeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | WellSpring Pharmaceutical Corporation | 65197-297 |
| Bonine Maxmeclizine hydrochloride | Meclizine hydrochloride 50 mg/1 | Tablet, ChewableOral | WellSpring Pharmaceutical Corporation | 65197-520 |
| Childrens Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | DeMoulas Market Basket | 53942-505 |
| CVS Motion Sickness Fast Meltingmeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, Orally disintegratingOral | CVS Pharmacy, Inc. | 59779-534 |
| Dimenhydrinate | Dimenhydrinate 50 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6772 |
| Dimenhydrinate | Dimenhydrinate 50 mg/1 | TabletOral | CVS Pharmacy, Inc. | 69842-206 |
| Dimenhydrinate | Dimenhydrinate 50 mg/1 | TabletOral | LEADER/ Cardinal Health 110, Inc. | 70000-0404 |
| Dramaminemeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | Medtech Products Inc. | 63029-906 |
| Dramaminemeclizine hydrochloride | Meclizine dihydrochloride 50 mg/1 | PowderOral | Medtech Products Inc. | 63029-912 |
| Dramaminemeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | Medtech Products Inc. | 63029-913 |
| Dramaminemeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | Medtech Products Inc. | 63029-914 |
| Dramaminedimenhydrinate | Dimenhydrinate 50 mg/1 | Tablet, ChewableOral | Lil' Drug Store Products, Inc. | 66715-9809 |
| Dramamine - Nmeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Medtech Products Inc. | 63029-905 |
| Dramamine Chewable Orangemeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | Medtech Products Inc. | 63029-915 |
| Dramamine for Kidsdimenhydrinate | Dimenhydrinate 25 mg/1 | Tablet, ChewableOral | Medtech Products Inc. | 63029-904 |
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