CLEMASTINE FUMARATE

Product NDC: 62135-713
Requested package NDC: 62135-713-41
11-digit product format: 621350713
Labeler code: 62135
Product ID: 62135-713_ffe63870-181f-e007-e053-6294a90a074e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLEMASTINE FUMARATE
Dosage form: SYRUP
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA074884
Marketing category: ANDA
Marketing start: 1997-12-17
Substance: CLEMASTINE FUMARATE
Active strength: .67 mg/5mL
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 1.

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
A074884-001	CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA		1997-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A074884-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074884-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074884-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074884-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074884-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074884-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074884-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074884-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074884-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074884-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074884-001	AA	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074884-001	AA	1	`a50c72e98297…`

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	.67 mg/5mL

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
857430	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6663f1b0-5353-401f-b9d3-d9f69ad08fbf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f7e17947-a18d-ce47-e13b-48f8b11c0c6f	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62135-713-41	CLEMASTINE FUMARATE	120 mL in 1 BOTTLE	SYRUP	120		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-713-41	ML - Milliliter	62135-713	ef7d22e7-d6c1-4b58-b525-667771ca6642	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-713	CLEMASTINE FUMARATE SYRUP [CHARTWELL RX, LLC]	1	Current NDC, 1 package rows	20230708_6663f1b0-5353-401f-b9d3-d9f69ad08fbf.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	Chartwell RX, LLC	6663f1b0-5353-401f-b9d3-d9f69ad08fbf	2023-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074884 application number: ANDA074884 ndc (package): 62135-713-41 ndc (product): 62135-713 ndc11 (package): 62135071341

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19259EGQ3D	CLEMASTINE FUMARATE	14976-57-9	CLEMASTINE FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857430	clemastine 0.5 MG in 5 mL Oral Solution	PSN	6663f1b0-5353-401f-b9d3-d9f69ad08fbf	1
857430	clemastine fumarate 0.134 MG/ML Oral Solution	SCD	6663f1b0-5353-401f-b9d3-d9f69ad08fbf	1
857430	clemastine 0.5 MG per 5 ML Oral Solution	SY	6663f1b0-5353-401f-b9d3-d9f69ad08fbf	1
857430	clemastine fumarate 0.67 MG per 5 ML Syrup	SY	6663f1b0-5353-401f-b9d3-d9f69ad08fbf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-713-41	62135071341	120 mL in 1 BOTTLE (62135-713-41)	120 ml	2023-07-07	No	No	Current