Home NDC 71085-081 CLEMSZA
Product NDC 71085-081
11-digit product format 710850081
Labeler code 71085
Product ID 71085-081_5d1c62ed-2759-1ca8-e063-6294a90a6560
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clemastine Fumarate
Dosage form TABLET
Route ORAL
Labeler IPG Pharmaceuticals, Inc.
Application ANDA073283
Marketing category ANDA
Marketing start 2025-08-01
Substance CLEMASTINE FUMARATE
Active strength 2.68 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A073283-001 CLEMASTINE FUMARATE 2.68MG TABLET / ORAL RS 1992-01-31 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CLEMSZA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLEMASTINE FUMARATE 2.68 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71085-081-30 CLEMSZA 30 in 1 BOTTLE TABLET 30 1
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 · 1 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 71085-081-30 71085008130 30 TABLET in 1 BOTTLE (71085-081-30) 30 tablet 2025-08-01 No No Current