Antivert

Product NDC
70199-003
Requested package NDC
70199-003-99
11-digit product format
701990003
Labeler code
70199
Product ID
70199-003_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
25 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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70199-00370199-003-99DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 5 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70199-00370199-003-99DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70199-00370199-003-99DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70199-00370199-003-99DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70199-00370199-003-99DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70199-00370199-003-99DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N010721-001ANTIVERTMECLIZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20
N010721-004ANTIVERTMECLIZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982
N010721-005ANTIVERTMECLIZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982
N010721-006ANTIVERTMECLIZINE HYDROCHLORIDE12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N010721-001AA
N010721-004AA
N010721-006AA

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 149 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N010721-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N010721-004AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N010721-006AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-004AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-006AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08N010721-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N010721-004AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N010721-006AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-004AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-006AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-004AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-006AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-004AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-006AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-004AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-006AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-004AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-006AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010721-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010721-004AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010721-006AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N010721-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10N010721-004AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10N010721-006AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N010721-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N010721-004AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N010721-006AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N010721-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N010721-004AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N010721-006AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N010721-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N010721-004AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N010721-006AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N010721-001AA18072bd15b7f6…

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.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacyc6b3f4d8-5fcf-2278-e053-2a95a90ab1392026-06-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.d7d31433-8f39-4fe6-b542-1b4410122db72026-06-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepack81e1762b-e012-4c6d-96e6-9a9f27a1880a2026-05-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEREMEDYREPACK INC.21d4a6ee-0a66-45d7-bab9-c5eef399713d2026-05-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEREMEDYREPACK INC.d53bf04e-5cfc-4974-9b24-2cce545d1bd02026-04-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.c31846b2-d47d-a97b-e053-2a95a90a9bec2026-03-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.beb36d86-9fb7-1f60-e053-2995a90aac132026-03-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepack112103bc-25e2-42cf-8542-ba1d3392a2c32025-08-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepack27b6a7e0-a361-4705-9f31-719063a65f222025-08-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERising Pharma Holdings, Inc.c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd2025-06-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2d31ae73-3f09-a77c-e063-6294a90ade9a2025-02-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDirectRxd27fe828-4fee-3ba9-e053-2995a90ae7b62025-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEProficient Rx LP92e8390b-5173-4aa1-906d-35d2c0eaaaf62024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEDirect_Rxe79ecf77-0e0a-d7ef-e053-2a95a90a5adf2024-04-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAsclemed USA, Inc.e6a5df4b-5cbf-4a0c-b38a-f4509c9c17db2024-04-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEProficient Rx LPb91435d1-fb95-4939-8478-84e41f44f7322023-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70199-003-01EA - Each70199-003415d3af9-42d7-4425-bde8-7e3e86e1c9a312022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70199-003-99701990003991000 TABLET in 1 BOTTLE (70199-003-99) 1000 tablet2020-01-150000-00-00NoNoCurrent