Over-the-counter drug · OTC MONOGRAPH DRUG
Meclizine (Meclizine hcl 25mg) NDC 43063-804
Meclizine hydrochloride 25 mg/1 · Tablet, Chewable · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)43063-804Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0804Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-804-01 | 4306308040143063080401 | 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-01)Marketed from Feb 18, 2018 | |
| 43063-804-06 | 4306308040643063080406 | 6 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-06)Marketed from Jul 23, 2018 | |
| 43063-804-12 | 4306308041243063080412 | 12 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-12)Marketed from Feb 1, 2018 | |
| 43063-804-20 | 4306308042043063080420 | 20 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-20)Marketed from Feb 1, 2018 | |
| 43063-804-30 | 4306308043043063080430 | 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-30)Marketed from Feb 1, 2018 |
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 25mg
- Active ingredients
- Meclizine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- 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 43063-804_2fb4b0a4-ecff-437f-e063-6394a90a2d5fSPL ID 2fb4b0a4-ecff-437f-e063-6394a90a2d5fSPL set ID cf79ac74-017e-4fb4-85d3-4ea944080e89RxCUI 995632UNII HDP7W44CIOUPC 0343063804124
- 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
N443063080401followed by a unit qualifier and the quantityPackage 43063-0804-01. 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)
Uses prevents and treats nausea, vomiting or dizziness associated with motion sickness
Excerpt only. Read the full label for complete information.
About NDC 43063-804
- What is NDC 43063-804?
- 43063-804 is the product NDC for Meclizine (meclizine hcl 25mg), Meclizine hydrochloride 25 mg/1 tablet, chewable, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Meclizine (Meclizine HCl 25mg).
- What is the active ingredient?
- Meclizine hydrochloride.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 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 | 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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