Over-the-counter drug · OTC MONOGRAPH DRUG
Meclizine (Meclizine hydrochloride) NDC 80513-421
Meclizine hydrochloride 25 mg/1 · Tablet, Chewable · Oral · Advanced Rx LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)80513-421Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80513-0421Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80513-421-02 | 8051304210280513042102 | 200 TABLET, CHEWABLE in 1 BOTTLE (80513-421-02)Marketed from Dec 1, 2024 |
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 hydrochloride
- Active ingredients
- Meclizine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Chewable
- 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 80513-421_27e17bc9-1e66-cc1f-e063-6394a90a4dcbSPL ID 27e17bc9-1e66-cc1f-e063-6394a90a4dcbSPL set ID b0a2a1f7-354e-48bd-9e98-9207bf9f53fdRxCUI 995632UNII 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
N480513042102followed by a unit qualifier and the quantityPackage 80513-0421-02. 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 80513-421
- What is NDC 80513-421?
- 80513-421 is the product NDC for Meclizine (meclizine hydrochloride), Meclizine hydrochloride 25 mg/1 tablet, chewable, 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 Hydrochloride).
- 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 hcl 12.5 mg | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Advanced Rx LLC | 80513-427 | 80513-0427-02 |
| 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 |
|---|---|---|---|---|
| Travel-Easemeclizine hcl | Meclizine hydrochloride 25 mg/1 | TabletOral | Geri-Care Pharmaceutical Corp | 57896-378 |
| Meclizine HCL 25 mgmeclizine hcl | Meclizine hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1607 |
| MQ Motion Patchmotion patch | Menthol 2 g/1001; Ginger 1 g/1001 | PatchTopical | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 83781-012 |
| Motion Sickness Reliefdimenhydrinate 50 mg | Dimenhydrinate 50 mg/1 | TabletOral | TARGET CORPORATION | 11673-354 |
| Motion Sickness Reliefmeclizine hcl | Meclizine hydrochloride 25 mg/1 | TabletOral | Meijer Distribution Inc | 41250-930 |
| Meclizine HCL 12.5 mg | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Proficient Rx LP | 71205-762 |
| Motion Sickness Reliefmeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | TARGET CORPORATION | 11673-356 |
| Motion Sickness Reliefmeclizine hcl | Meclizine hydrochloride 25 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-304 |
| Motion Sicknessmotion sickness natural herbal plant | Menthol glucuronide 10 mg/10g; Camphor, (-)- 20 mg/10g | PatchTopical | Puning Huiyu E-Commerce Co., Ltd. | 85213-001 |
| HIONFURT Motion Sicknessmotion sickness prevent nausea,dizziness vomiting | Cinnamon oil 10 mg/100g + 3 more ingredients | PatchTopical | Puning Huiyu E-Commerce Co., Ltd. | 85213-005 |
| Meclizinemeclizine hcl 12.5 mg | Meclizine hydrochloride 12.5 mg/1 | TabletOral | RUGBY LABORATORIES | 0536-1297 |
| HIONFURT Motion Sicknessmotion sickness natural herbal plant lemon | Menthol glucuronide 10 mg/100g; Camphor, (-)- 20 mg/100g | PatchTopical | Puning Huiyu E-Commerce Co., Ltd. | 85213-002 |
| HIONFURT Motion Sicknessmotion sickness natural herbal plant | Camphor, (-)- 20 mg/100g; Menthol glucuronide 10 mg/100g | PatchTopical | Puning Huiyu E-Commerce Co., Ltd. | 85213-003 |
| HIONFURT Motion Sicknessmotion sickness natural herbal plant lavender | Camphor, (-)- 20 mg/100g; Menthol glucuronide 10 mg/100g | PatchTopical | Puning Huiyu E-Commerce Co., Ltd. | 85213-004 |
| PhysiciansCare Motion Sicknessmeclizine hcl | Meclizine hydrochloride 25 mg/1 | TabletOral | Acme United Corporation | 0924-1008 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | A-S Medication Solutions | 50090-5496 |
| Meclizinemeclizine hcl 12.5 mg | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Advanced Rx LLC | 80513-427 |
| Motion Sickness Reliefmeclizine hcl | Meclizine hydrochloride 25 mg/1 | TabletOral | DOLGENCORP, LLC | 55910-943 |
| Motion Sicknessdimenhydrinate | Dimenhydrinate 50 mg/1 | TabletOral | CVS Pharmacy | 59779-198 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | CVS Pharmacy, Inc | 69842-857 |
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