Home NDC 64950-268 Clemastine Fumarate
Product NDC 64950-268
11-digit product format 649500268
Labeler code 64950
Product ID 64950-268_813d92a9-7e67-455e-9158-6aa5af5b27a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clemastine Fumarate
Dosage form TABLET
Route ORAL
Labeler Genus Lifesciences
Application ANDA073283
Marketing category ANDA
Marketing start 2024-11-20
Substance CLEMASTINE FUMARATE
Active strength 2.68 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A073283-001 CLEMASTINE FUMARATE CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31
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 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Clemastine Fumarate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLEMASTINE FUMARATE 2.68 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 19259EGQ3D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857461 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64950-268-03 Clemastine Fumarate 30 in 1 BOTTLE TABLET 30 2 64950-268-10 Clemastine Fumarate 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64950-268 CLEMASTINE FUMARATE TABLET [GENUS LIFESCIENCES] 2 Current NDC, 2 package rows 20250206_cf8a3449-8bb3-4d5c-8d0d-557590e49ee5.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64950-268-03 64950026803 30 TABLET in 1 BOTTLE (64950-268-03) 30 tablet 2024-11-20 No No Current 64950-268-10 64950026810 100 TABLET in 1 BOTTLE (64950-268-10) 100 tablet 2024-11-20 No No Current