Prescription drug · ANDA
Meclizine Hydrochloride (Meclizine hydrocloride) NDC 70518-1308
Meclizine hydrochloride 25 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1308-0 | 7051813080070518130800 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1308-0)Marketed from Aug 17, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hydrocloride
- Active ingredients
- Meclizine hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040659
- Marketing start
- Marketing end
- Other FDA classes
- Emesis Suppression (Physiologic effect)
- Identifiers
- Product ID 70518-1308_55b97831-b268-966d-e063-6294a90a3e29SPL ID 55b97831-b268-966d-e063-6294a90a3e29SPL set ID ba2fb6de-af86-4c05-9018-135e1f8594f9RxCUI 995666UNII HDP7W44CIO
- 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
N470518130800followed by a unit qualifier and the quantityPackage 70518-1308-00. 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 is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride 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.
About NDC 70518-1308
- What is NDC 70518-1308?
- 70518-1308 is the product NDC for Meclizine Hydrochloride (meclizine hydrocloride), Meclizine hydrochloride 25 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Meclizine Hydrochloride (Meclizine Hydrocloride).
- What is the active ingredient?
- Meclizine hydrochloride.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. 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 Hydrochloride?
- 83 other product NDCs are listed under this name. See all Meclizine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Meclizine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 25 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-997 | 60760-0997-30 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Coupler LLC | 67046-0869 | 67046-0869-03 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4170 | 68788-4170-0168788-4170-03 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 50 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-943 | 23155-0943-0123155-0943-10 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0494 | 80425-0494-0180425-0494-0280425-0494-03 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-058 | 82868-0058-2082868-0058-30 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8633 | 68788-8633-0168788-8633-03 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-7417 | 50090-7417-0050090-7417-0150090-7417-04+1 more |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-7416 | 50090-7416-02 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-809 | 59651-0809-0559651-0809-90 |
Other NDCs under ANDA 040659
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 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-107 |
| Meclizine Hydrochloridemeclizine hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-121 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-122 |
| Meclizine Hydrochloridemeclizine hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Proficient Rx LP | 63187-996 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2432 |
| Meclizine Hydrochloridemeclizine hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3017 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Proficient Rx LP | 71205-416 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0153 |
| Meclizine Hydrochloridemeclizine hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0503 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1563 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1690 |
| Meclizine Hydrochloridemeclizine hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-130 |
| Meclizine Hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | QPharma Inc | 42708-102 |