MECLIZINE HYDROCHLORIDE
- Product NDC
- 53002-3510
- 11-digit product format
- 530023510
- Labeler code
- 53002
- Product ID
- 53002-3510_711d949e-e43b-46bd-a3d1-d0c20be7d147
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Meclizine Hydrocloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA040659
- Marketing category
- ANDA
- Marketing start
- 2010-06-04
- Marketing end
- 0000-00-00
- Substance
- MECLIZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antiemetic [EPC],Emesis Suppression [PE]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ac6963c4-31c6-325f-ee58-83a0a06597ad | Product name | 5 | 20221206 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-3510-1 | MECLIZINE HYDROCHLORIDE | 10 in 1 BOTTLE | TABLET | 10 | 5 | |
| 53002-3510-2 | MECLIZINE HYDROCHLORIDE | 20 in 1 BOTTLE | TABLET | 20 | 5 | |
| 53002-3510-3 | MECLIZINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-3510 | MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 3 package rows | 20230609_e340262a-4018-4b5b-a580-ead858907b12.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995666 | meclizine HCl 25 MG Oral Tablet | PSN | e340262a-4018-4b5b-a580-ead858907b12 | 5 |
| 995666 | meclizine hydrochloride 25 MG Oral Tablet | SCD | e340262a-4018-4b5b-a580-ead858907b12 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-3510-1 | 53002351001 | 10 TABLET in 1 BOTTLE (53002-3510-1) | 10 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-3510-2 | 53002351002 | 20 TABLET in 1 BOTTLE (53002-3510-2) | 20 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-3510-3 | 53002351003 | 30 TABLET in 1 BOTTLE (53002-3510-3) | 30 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |