Home NDC 0093-0308-01 Clemastine Fumarate
Product NDC 0093-0308
Requested package NDC 0093-0308-01
11-digit product format 000930308
Labeler code 0093
Product ID 0093-0308_d4195d2d-40c5-4e06-8298-1ac90b0cbb3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clemastine Fumarate
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA073283
Marketing category ANDA
Marketing start 1992-04-01
Marketing end 0000-00-00
Substance CLEMASTINE FUMARATE
Active strength 3 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-0308 CLEMASTINE FUMARATE TABLET [TEVA PHARMACEUTICALS USA, INC.] 10 Legacy NDC 20241208_14aaadca-7d86-47e8-8483-6e05d456949d.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0093-0308-01 00093030801 100 TABLET in 1 BOTTLE (0093-0308-01) 100 tablet 1992-04-01 0000-00-00 No No Current