Over-the-counter drug · OTC MONOGRAPH DRUG
Bonine (Meclizine hydrochloride) NDC 65197-275
Meclizine hydrochloride 25 mg/1 · Tablet, Chewable · Oral · WellSpring Pharmaceutical Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65197-275-02 | 6519702750265197027502 | 2 TABLET, CHEWABLE in 1 POUCH (65197-275-02)Marketed from Dec 15, 2014 | |
| 65197-275-08 | 6519702750865197027508 | 1 BLISTER PACK in 1 BOX (65197-275-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 15, 2014 | |
| 65197-275-12 | 6519702751265197027512 | 1 BOTTLE in 1 BOX (65197-275-12) / 12 TABLET, CHEWABLE in 1 BOTTLEMarketed from Dec 15, 2014 | |
| 65197-275-16 | 6519702751665197027516 | 2 BLISTER PACK in 1 BOX (65197-275-16) / 8 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 15, 2014 |
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)
- Bonine
- Generic name (nonproprietary)
- meclizine hydrochloride
- Active ingredients
- Meclizine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- WellSpring Pharmaceutical CorporationNDC labeler code 65197
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 009
- Marketing start
- Marketing end
- Other FDA classes
- Emesis Suppression (Physiologic effect)
- Identifiers
- Product ID 65197-275_7c66f984-240b-40dc-affd-9f1562f57c7cSPL ID 7c66f984-240b-40dc-affd-9f1562f57c7cSPL set ID ad3d66ca-a52c-43ba-b9e2-6269b8a413a9RxCUI 995632, 995634UNII HDP7W44CIOUPC 0365197275120, 0365197275083
- 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
N465197027502followed by a unit qualifier and the quantityPackage 65197-0275-02. 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 65197-275
- What is NDC 65197-275?
- 65197-275 is the product NDC for Bonine (meclizine hydrochloride), Meclizine hydrochloride 25 mg/1 tablet, chewable, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bonine (Meclizine hydrochloride).
- What is the active ingredient?
- Meclizine hydrochloride.
- Who is the labeler?
- WellSpring Pharmaceutical Corporation, NDC labeler code 65197. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bonine?
- 2 other product NDCs are listed under this name. See all Bonine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bonine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Boninemeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | WellSpring Pharmaceutical Corporation | 65197-297 | 65197-0297-0865197-0297-1265197-0297-16+2 more |
| Boninemeclizine hydrochloride | Meclizine hydrochloride 25 mg/1 | Tablet, ChewableOral | WellSpring Pharmaceutical Corporation | 65197-296 | 65197-0296-0865197-0296-1265197-0296-16+1 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 | 65197-296 |
| 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 |
| Dramamine for Kidsdimenhydrinate | Dimenhydrinate 25 mg/1 | Tablet, ChewableOral | Medtech Products Inc. | 63029-908 |
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