FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
67296-2250
Requested package NDC
67296-2250-3
11-digit product format
672962250
Labeler code
67296
Product ID
67296-2250_52ee8486-dfad-4e68-e063-6294a90a8476
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MECLIZINE
Dosage form
TABLET
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA202640
Marketing category
ANDA
Marketing start
2023-09-14
Substance
MECLIZINE HYDROCHLORIDE
Active strength
12.5 mg/1
Pharmacologic classes
Antiemetic [EPC]; Emesis Suppression [PE]
Listing certified through
2027-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202640-001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-17
A202640-002MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-17
A202640-003MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202640-001AA
A202640-002AA
A202640-003AA

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-17a50c72e98297…
2026-08-01 22:54:322026-06A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-17a50c72e98297…
2026-08-01 22:54:322026-06A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202640-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A202640-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A202640-003AA1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MECLIZINE HYDROCHLORIDEMECLIZINEBryant Ranch Prepackdab43efd-bec6-472f-b13a-1c043914dcd12026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINEBryant Ranch Prepack1079db3f-d8ad-4c25-aa91-8ac8054ee4f22026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINERedpharm Drug52ee9258-8311-e6bd-e063-6294a90a567f2026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
ndc (package): 67296-2250-3
ndc (product): 67296-2250
ndc11 (package): 67296225003
MECLIZINE HYDROCHLORIDEMECLIZINERedpharm Drug4727e7a9-eabb-a2a7-e063-6394a90a87542026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINEA-S Medication Solutions55e262d9-d9dd-43a3-bc74-35e46dd391be2024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINEA-S Medication Solutions949f7347-8c3a-43ce-b975-8d187096f09f2024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINENCS HealthCare of KY, LLC dba Vangard Labs1a33dec1-8d59-48bd-aaef-77d162194d572024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINEAurobindo Pharma Limitedbeb3c7f2-c0f4-41d9-a903-63a6847e09972023-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640

Additional Listing Data#

Finished product
Yes
Brand name base
MECLIZINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE12.5 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52ee9258-8311-e6bd-e063-6294a90a567fAvailable on FDA.report

DailyMed Product Concepts#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
67296-2250-36729622500330 TABLET in 1 BOTTLE (67296-2250-3)30 tablet2023-09-140Current