Antivert
- Product NDC
- 70199-004
- 11-digit product format
- 701990004
- Labeler code
- 70199
- Product ID
- 70199-004_085f1a70-ff63-4c02-ac05-2579fe2ef002
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- meclizine hcl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Casper Pharma LLC
- Application
- NDA010721
- Marketing category
- NDA
- Marketing start
- 2020-01-15
- Marketing end
- 0000-00-00
- Substance
- MECLIZINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Antiemetic [EPC], Emesis Suppression [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70199-004 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 70199-004 | 70199-004-01 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 70199-004 | 70199-004-99 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N010721-001 | ANTIVERT | MECLIZINE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 |
| N010721-004 | ANTIVERT | MECLIZINE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | |
| N010721-005 | ANTIVERT | MECLIZINE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | ||
| N010721-006 | ANTIVERT | MECLIZINE HYDROCHLORIDE | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N010721-001 | AA |
| N010721-004 | AA |
| N010721-006 | AA |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N010721-001 | ANTIVERT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N010721-004 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N010721-005 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N010721-006 | ANTIVERT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N010721-001 | AA | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N010721-004 | AA | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N010721-006 | AA | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | c6b3f4d8-5fcf-2278-e053-2a95a90ab139 | 2026-06-21 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | d7d31433-8f39-4fe6-b542-1b4410122db7 | 2026-06-12 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Bryant Ranch Prepack | 81e1762b-e012-4c6d-96e6-9a9f27a1880a | 2026-05-27 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | REMEDYREPACK INC. | 21d4a6ee-0a66-45d7-bab9-c5eef399713d | 2026-05-13 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | REMEDYREPACK INC. | d53bf04e-5cfc-4974-9b24-2cce545d1bd0 | 2026-04-15 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | c31846b2-d47d-a97b-e053-2a95a90a9bec | 2026-03-27 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | beb36d86-9fb7-1f60-e053-2995a90aac13 | 2026-03-02 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Bryant Ranch Prepack | 112103bc-25e2-42cf-8542-ba1d3392a2c3 | 2025-08-20 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Bryant Ranch Prepack | 27b6a7e0-a361-4705-9f31-719063a65f22 | 2025-08-20 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd | 2025-06-02 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 2d31ae73-3f09-a77c-e063-6294a90ade9a | 2025-02-02 | Warnings, Adverse reactions | 010721 NDA010721 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | DirectRx | d27fe828-4fee-3ba9-e053-2995a90ae7b6 | 2025-01-20 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Proficient Rx LP | 92e8390b-5173-4aa1-906d-35d2c0eaaaf6 | 2024-08-01 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Direct_Rx | e79ecf77-0e0a-d7ef-e053-2a95a90a5adf | 2024-04-09 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Asclemed USA, Inc. | e6a5df4b-5cbf-4a0c-b38a-f4509c9c17db | 2024-04-08 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Proficient Rx LP | b91435d1-fb95-4939-8478-84e41f44f732 | 2023-04-01 | Warnings, Adverse reactions | 010721 NDA010721 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70199-004-01 | EA - Each | 70199-004 | 44c62ded-2654-4cab-a105-decc2ea5f8f7 | 1 | 2021-08-05 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70199-004-01 | 70199000401 | 100 TABLET in 1 BOTTLE (70199-004-01) | 100 tablet | 2020-01-15 | 0000-00-00 | No | No | Current |
| 70199-004-99 | 70199000499 | 1000 TABLET in 1 BOTTLE (70199-004-99) | 1000 tablet | 2020-01-15 | 0000-00-00 | No | No | Current |