Clemastine Fumarate
- Product NDC
- 0093-0308
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0093-0308 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 0093-0308 | 0093-0308-01 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| 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.
| 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… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-0308-01 | EA - Each | 0093-0308 | 33c4e417-b074-4413-98ac-02b4a7524072 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CLEMASTINE FUMARATE | ACTIVE INGREDIENT | 19259EGQ3D | CLEMASTINE FUMARATE TABLET [TEVA PHARMACEUTICALS USA INC] | 4 | |
| CLEMASTINE | ACTIVE MOIETY | 95QN29S1ID | CLEMASTINE FUMARATE TABLET [TEVA PHARMACEUTICALS USA INC] | 4 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | CLEMASTINE FUMARATE TABLET [TEVA PHARMACEUTICALS USA INC] | 4 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | CLEMASTINE FUMARATE TABLET [TEVA PHARMACEUTICALS USA INC] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLEMASTINE FUMARATE TABLET [TEVA PHARMACEUTICALS USA INC] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CLEMASTINE FUMARATE TABLET [TEVA PHARMACEUTICALS USA INC] | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | CLEMASTINE FUMARATE TABLET [TEVA PHARMACEUTICALS USA INC] | 4 | |
| CLEMASTINE FUMARATE | ACTIVE INGREDIENT | 19259EGQ3D | CLEMASTINE FUMARATE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | |
| CLEMASTINE | ACTIVE MOIETY | 95QN29S1ID | CLEMASTINE FUMARATE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CLEMSZA | CLEMASTINE FUMARATE | IPG Pharmaceuticals, Inc. | 9a35ed77-e35c-4c54-ad7f-1b92e450fa20 | 2025-07-30 | Warnings, Adverse reactions | 073283 ANDA073283 |
| Clemastine Fumarate | CLEMASTINE FUMARATE | Genus Lifesciences | cf8a3449-8bb3-4d5c-8d0d-557590e49ee5 | 2025-02-03 | Warnings, Adverse reactions | 073283 ANDA073283 |
Packages#
| 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 |