MECLIZINE HYDROCHLORIDE

Product NDC
59746-121
11-digit product format
597460121
Labeler code
59746
Product ID
59746-121_ead33f00-e158-464f-953f-ab5a9a391199
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrocloride
Dosage form
TABLET
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA040659
Marketing category
ANDA
Marketing start
2010-06-04
Marketing end
2026-10-31
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-121-10IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-121-06IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-121-10IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-121-06IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-121-10IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-121-06IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-121-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-121-06IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-121-10UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-121-06UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-121-10UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-121-06UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-121-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-121-06UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040659-001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04
A040659-002MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040659-001AA
A040659-002AA

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040659-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040659-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040659-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040659-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040659-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040659-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040659-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040659-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040659-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040659-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040659-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040659-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040659-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040659-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040659-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040659-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040659-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040659-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040659-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040659-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040659-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040659-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040659-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040659-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040659-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040659-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040659-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040659-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040659-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040659-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040659-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040659-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040659-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040659-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040659-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040659-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040659-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040659-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040659-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040659-002AA1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
MECLIZINE HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HDP7W44CIOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995624Internal RxNorm lookup
995666Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9350fefc-9c00-182c-c3a9-044d4a40856fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-121-06MECLIZINE HYDROCHLORIDE100 in 1 BOTTLETABLET1008
59746-121-10MECLIZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-121-06EA - Each59746-121426b1544-2026-4b5e-92b6-b06bf4ad888312012-07-24
59746-121-10EA - Each59746-121ef373495-c09a-4243-9246-5944249609e512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Meclizine HydrochlorideACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Meclizine HydrochlorideACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Meclizine HydrochlorideACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
MeclizineACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
MeclizineACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Fd&c Blue No. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Fd&c Blue No. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
Meclizine HydrochlorideACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
MeclizineACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
Fd&c Blue No. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-121MECLIZINE HYDROCHLORIDE TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20191221_9350fefc-9c00-182c-c3a9-044d4a40856f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEREMEDYREPACK INC.ba2fb6de-af86-4c05-9018-135e1f8594f92026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDENorthwind Health Company, LLCc443873a-2e89-43b2-b145-dde3dadf7bc02026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
Meclizine HydroclorideMECLIZINE HYDROCLORIDEQPharma Incaa0fb895-a867-4482-9bc2-16eee8bfaaa02025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEBryant Ranch Prepack522b55a2-313c-45e8-b1be-07746ada5b0a2025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEBryant Ranch Prepackf43bf077-3f29-48ec-8ca8-eb294dbf20012025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEBryant Ranch Prepack6dd657ba-46dc-4106-9f6a-dfa0ecf857522025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEBryant Ranch Prepack6c66ee38-10bb-4559-9d2f-51e6d6f091ee2025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEJubilant Cadista Pharmacuticals Inc.9350fefc-9c00-182c-c3a9-044d4a40856f2025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
ndc (product): 59746-121
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDENuCare Pharmaceuticals,Inc.64a508ae-768a-2fba-e053-2991aa0ac42d2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEProficient Rx LP6a8cbc12-0725-4462-bb71-0b18cefc19e72023-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEProficient Rx LPf574e123-8db7-4e3d-a0ee-e4e1f04ff1462022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEAsclemed USA, Inc.5c70e61b-a1e6-4981-92e2-1050cee08baa2020-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEBryant Ranch Prepack53f410fd-104c-42c1-9740-6f48ffbc974f2020-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNf43bf077-3f29-48ec-8ca8-eb294dbf2001101
995666meclizine hydrochloride 25 MG Oral TabletSCDf43bf077-3f29-48ec-8ca8-eb294dbf2001101
995666meclizine HCl 25 MG Oral TabletPSNba2fb6de-af86-4c05-9018-135e1f8594f919
995666meclizine hydrochloride 25 MG Oral TabletSCDba2fb6de-af86-4c05-9018-135e1f8594f919
995666meclizine HCl 25 MG Oral TabletPSNea4a354b-05fe-47b4-9e96-bc7b5c4cadf29
995666meclizine HCl 25 MG Oral TabletPSN648570f0-2def-4d15-87bc-ca631439e7f49
995666meclizine hydrochloride 25 MG Oral TabletSCDea4a354b-05fe-47b4-9e96-bc7b5c4cadf29
995666meclizine hydrochloride 25 MG Oral TabletSCD648570f0-2def-4d15-87bc-ca631439e7f49
995624meclizine HCl 12.5 MG Oral TabletPSN9350fefc-9c00-182c-c3a9-044d4a40856f8
995666meclizine HCl 25 MG Oral TabletPSN4e3ca2b3-8e1e-439f-e054-00144ff88e888
995666meclizine HCl 25 MG Oral TabletPSN9350fefc-9c00-182c-c3a9-044d4a40856f8
995624meclizine hydrochloride 12.5 MG Oral TabletSCD9350fefc-9c00-182c-c3a9-044d4a40856f8
995666meclizine hydrochloride 25 MG Oral TabletSCD4e3ca2b3-8e1e-439f-e054-00144ff88e888
995666meclizine hydrochloride 25 MG Oral TabletSCD9350fefc-9c00-182c-c3a9-044d4a40856f8
995666meclizine HCl 25 MG Oral TabletPSNf574e123-8db7-4e3d-a0ee-e4e1f04ff1466
995666meclizine hydrochloride 25 MG Oral TabletSCDf574e123-8db7-4e3d-a0ee-e4e1f04ff1466
995666meclizine HCl 25 MG Oral TabletPSN64a508ae-768a-2fba-e053-2991aa0ac42d5
995666meclizine HCl 25 MG Oral TabletPSNaa0fb895-a867-4482-9bc2-16eee8bfaaa05
995666meclizine HCl 25 MG Oral TabletPSNc443873a-2e89-43b2-b145-dde3dadf7bc05
995666meclizine HCl 25 MG Oral TabletPSNe340262a-4018-4b5b-a580-ead858907b125
995666meclizine hydrochloride 25 MG Oral TabletSCD64a508ae-768a-2fba-e053-2991aa0ac42d5
995666meclizine hydrochloride 25 MG Oral TabletSCDaa0fb895-a867-4482-9bc2-16eee8bfaaa05
995666meclizine hydrochloride 25 MG Oral TabletSCDc443873a-2e89-43b2-b145-dde3dadf7bc05
995666meclizine hydrochloride 25 MG Oral TabletSCDe340262a-4018-4b5b-a580-ead858907b125
995666meclizine HCl 25 MG Oral TabletPSN90a236e0-4a1a-f755-e053-2a95a90a08c32
995666meclizine HCl 25 MG Oral TabletPSN1167fc42-ed45-2c39-e054-00144ff88e882
995666meclizine HCl 25 MG Oral TabletPSN180aedec-8a48-4e56-8eed-7daff874161b2
995666meclizine hydrochloride 25 MG Oral TabletSCD1167fc42-ed45-2c39-e054-00144ff88e882
995666meclizine hydrochloride 25 MG Oral TabletSCD90a236e0-4a1a-f755-e053-2a95a90a08c32
995666meclizine hydrochloride 25 MG Oral TabletSCD180aedec-8a48-4e56-8eed-7daff874161b2
995666meclizine HCl 25 MG Oral TabletPSN04a7609c-45a7-412b-ba0e-e2de689ba1011
995666meclizine HCl 25 MG Oral TabletPSNe6a5b78d-1939-4632-ab83-90ca169e56e41
995666meclizine HCl 25 MG Oral TabletPSN478bac81-1b81-4c8e-b894-019c5a039b6d1
995666meclizine HCl 25 MG Oral TabletPSN5c70e61b-a1e6-4981-92e2-1050cee08baa1
995666meclizine HCl 25 MG Oral TabletPSN8fecbf38-56be-2323-e053-2995a90a78381
995666meclizine hydrochloride 25 MG Oral TabletSCDe6a5b78d-1939-4632-ab83-90ca169e56e41
995666meclizine hydrochloride 25 MG Oral TabletSCD478bac81-1b81-4c8e-b894-019c5a039b6d1
995666meclizine hydrochloride 25 MG Oral TabletSCD5c70e61b-a1e6-4981-92e2-1050cee08baa1
995666meclizine hydrochloride 25 MG Oral TabletSCD04a7609c-45a7-412b-ba0e-e2de689ba1011
995666meclizine hydrochloride 25 MG Oral TabletSCD8fecbf38-56be-2323-e053-2995a90a78381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-121-0659746012106100 TABLET in 1 BOTTLE (59746-121-06) 100 tablet2010-06-042026-10-31NoNoCurrent
59746-121-10597460121101000 TABLET in 1 BOTTLE (59746-121-10) 1000 tablet2010-06-042026-10-31NoNoCurrent