Prescription drug · ANDA
Meclizine Hydrochloride (Meclizine hydrocloride) NDC 76420-130
Meclizine hydrochloride 25 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-130-10 | 7642001301076420013010 | 10 TABLET in 1 BOTTLE (76420-130-10)Marketed from Oct 30, 2020 | |
| 76420-130-20 | 7642001302076420013020 | 20 TABLET in 1 BOTTLE (76420-130-20)Marketed from Oct 30, 2020 | |
| 76420-130-30 | 7642001303076420013030 | 30 TABLET in 1 BOTTLE (76420-130-30)Marketed from Oct 30, 2020 |
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 Hydrochloride
- Generic name (nonproprietary)
- meclizine hydrocloride
- Active ingredients
- Meclizine hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040659
- Marketing start
- Listing expires
- Other FDA classes
- Emesis Suppression (Physiologic effect)
- Identifiers
- Product ID 76420-130_b2ddcdd0-726a-99df-e053-2a95a90a8818SPL ID b2ddcdd0-726a-99df-e053-2a95a90a8818SPL set ID 5c70e61b-a1e6-4981-92e2-1050cee08baaRxCUI 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
N476420013010followed by a unit qualifier and the quantityPackage 76420-0130-10. 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 76420-130
- What is NDC 76420-130?
- 76420-130 is the product NDC for Meclizine Hydrochloride (meclizine hydrocloride), Meclizine hydrochloride 25 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 3 package NDCs, 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?
- Asclemed USA, Inc., NDC labeler code 76420. 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 Hydrochloridemeclizine hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1308 |
| 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 Hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | QPharma Inc | 42708-102 |