Home NDC 73308-358-12 Clemastine Fumarate
Product NDC 73308-358
Requested package NDC 73308-358-12
11-digit product format 733080358
Labeler code 73308
Product ID 73308-358_a5aed496-ff47-4b96-b6bc-57e26149203f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clemastine Fumarate
Dosage form SYRUP
Route ORAL
Labeler Ayurax, LLC
Application ANDA073399
Marketing category ANDA
Marketing start 2021-02-09
Marketing end 0000-00-00
Substance CLEMASTINE FUMARATE
Active strength 1 mg/5mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…
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 A073399-001 CLEMASTINE FUMARATE CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL AA RS 1994-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073399-001 AA
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 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL AA RS 1994-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL AA RS 1994-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL AA RS 1994-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL AA RS 1994-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL AA RS 1994-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL AA RS 1994-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL AA RS 1994-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL AA RS 1994-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL AA RS 1994-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL AA RS 1994-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL AA RS 1994-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073399-001 CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP / ORAL RS 1994-06-30 e64feba35796…
Observed Orange Book normalized TE history# 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 73308-358-12 73308035812 120 mL in 1 BOTTLE, PLASTIC (73308-358-12) 120 ml 2021-02-09 0000-00-00 No No Current