Meclizine Hydrochloride
- Product NDC
- 61919-146
- 11-digit product format
- 619190146
- Labeler code
- 61919
- Product ID
- 61919-146_f2027f74-cc96-4a11-e053-2a95a90aecf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Meclizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA040659
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- 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
- 2024-12-31
- 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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-146-20 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-09f7-f424-e053-dadaa90a57ce | Meclizine Hydrochloride |
| 61919-146-30 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-09f7-f424-e053-dadaa90a57ce | Meclizine Hydrochloride |
| 61919-146-10 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-eda8-a426-e053-dadaa90af4c2 | Meclizine Hydrochloride |
| 61919-146-90 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1e20-a910-e053-dadaa90a0b85 | Meclizine Hydrochloride |
| 61919-146-20 | 2021-01-07 | C162847 | 48780-1 | 9d75b9d0-09f7-f424-e053-dadaa90a57ce | Meclizine Hydrochloride |
| 61919-146-30 | 2021-01-07 | C162847 | 48780-1 | 9d75b9d0-09f7-f424-e053-dadaa90a57ce | Meclizine Hydrochloride |
| 61919-146-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-09f7-f424-e053-dadaa90a57ce | Meclizine Hydrochloride |
| 61919-146-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-09f7-f424-e053-dadaa90a57ce | Meclizine Hydrochloride |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-146-20 | Meclizine Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | 9 | |
| 61919-146-30 | Meclizine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 9 | |
| 61919-146-10 | Meclizine Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | 2 | |
| 61919-146-90 | Meclizine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-146-10 | EA - Each | 61919-146 | 19ad8fca-5b76-4a18-9b9e-d2ed186be04b | 1 | 2019-09-05 |
| 61919-146-20 | EA - Each | 61919-146 | 991ce28a-76c3-41be-81f6-49412476ed62 | 1 | 2014-06-03 |
| 61919-146-30 | EA - Each | 61919-146 | 4749e47b-9dea-4085-8939-78927a77bfbb | 1 | 2015-10-02 |
| 61919-146-90 | EA - Each | 61919-146 | 5ddd56ad-2296-467a-b971-0fed970fad99 | 1 | 2019-09-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Meclizine Hydrochloride | ACTIVE INGREDIENT | HDP7W44CIO | MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX] | 2 | |
| MECLIZINE | ACTIVE MOIETY | 3L5TQ84570 | MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX] | 2 | |
| Aluminum Oxide | INACTIVE INGREDIENT | LMI26O6933 | MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX] | 2 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX] | 2 | |
| Croscarmellose Sodium | INACTIVE INGREDIENT | M28OL1HH48 | MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX] | 2 | |
| Fd&c Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX] | 2 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX] | 2 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX] | 2 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-146 | MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX] | 9 | Legacy NDC, 2 package rows | 20230413_648570f0-2def-4d15-87bc-ca631439e7f4.zip |
| 61919-146 | MECLIZINE HYDROCHLORIDE TABLET [DIRECT_RX] | 2 | Legacy NDC, 1 package rows | 20200121_90a236e0-4a1a-f755-e053-2a95a90a08c3.zip |
| 61919-146 | MECLIZINE HYDROCHLORIDE TABLET [DIRECT_RX] | 1 | Legacy NDC, 1 package rows | 20190813_8fecbf38-56be-2323-e053-2995a90a7838.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995666 | meclizine HCl 25 MG Oral Tablet | PSN | 648570f0-2def-4d15-87bc-ca631439e7f4 | 9 |
| 995666 | meclizine hydrochloride 25 MG Oral Tablet | SCD | 648570f0-2def-4d15-87bc-ca631439e7f4 | 9 |
| 995666 | meclizine HCl 25 MG Oral Tablet | PSN | 90a236e0-4a1a-f755-e053-2a95a90a08c3 | 2 |
| 995666 | meclizine hydrochloride 25 MG Oral Tablet | SCD | 90a236e0-4a1a-f755-e053-2a95a90a08c3 | 2 |
| 995666 | meclizine HCl 25 MG Oral Tablet | PSN | 8fecbf38-56be-2323-e053-2995a90a7838 | 1 |
| 995666 | meclizine hydrochloride 25 MG Oral Tablet | SCD | 8fecbf38-56be-2323-e053-2995a90a7838 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-146-10 | 61919014610 | 10 TABLET in 1 BOTTLE (61919-146-10) | 10 tablet | 2019-08-21 | 0000-00-00 | No | No | Current |
| 61919-146-20 | 61919014620 | 20 TABLET in 1 BOTTLE (61919-146-20) | 20 tablet | 2014-01-01 | 0000-00-00 | No | No | Current |
| 61919-146-30 | 61919014630 | 30 TABLET in 1 BOTTLE (61919-146-30) | 30 tablet | 2014-01-01 | 0000-00-00 | No | No | Current |
| 61919-146-90 | 61919014690 | 90 in 1 BOTTLE | Historical |