CYPROHEPTADINE HYDROCHLORIDE

Product NDC: 17856-1185
11-digit product format: 178561185
Labeler code: 17856
Product ID: 17856-1185_5879a022-28c6-e608-e063-6294a90aee9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYPROHEPTADINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: ORAL
Labeler: Atlantic Biologicals Corp.
Application: ANDA212423
Marketing category: ANDA
Marketing start: 2023-12-22
Substance: CYPROHEPTADINE HYDROCHLORIDE
Active strength: 2 mg/5mL
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 43.

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
A212423-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA		2019-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212423-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212423-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212423-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212423-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212423-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212423-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212423-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212423-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212423-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212423-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212423-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212423-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212423-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212423-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212423-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212423-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212423-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212423-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212423-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212423-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212423-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212423-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212423-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212423-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212423-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212423-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212423-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212423-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212423-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A212423-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212423-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212423-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212423-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212423-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212423-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212423-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212423-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212423-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212423-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212423-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212423-001	AA	1	`f41ea6bd6efb…`

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: CYPROHEPTADINE HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYPROHEPTADINE HYDROCHLORIDE	2 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NJ82J0F8QC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866021	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
582b86c6-f9b2-278d-e063-6394a90a923d	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Atlantic Biologicals Corp.	582b86c6-f9b2-278d-e063-6394a90a923d	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212423 application number: ANDA212423 ndc (product): 17856-1185
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	996dd4c6-ebcf-42e8-a950-9d34bb6f404f	2025-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212423 application number: ANDA212423
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	QUAGEN PHARMACEUTICALS LLC	d3ce21de-849a-47ab-8405-968d8de6f1e9	2024-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212423 application number: ANDA212423

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NJ82J0F8QC	CYPROHEPTADINE HYDROCHLORIDE	41354-29-4	CYPROHEPTADINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
17856-1185-1	17856118501	72 CUP, UNIT-DOSE in 1 CASE (17856-1185-1) / 5 mL in 1 CUP, UNIT-DOSE		2026-08-04	No	No	Current
17856-1185-2	17856118502	120 SYRINGE in 1 CASE (17856-1185-2) / 2.5 mL in 1 SYRINGE	120 syringe	2026-08-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
17856-1185 Cyproheptadine Hydrochloride Oral Solution, USP, 2 mg/5 mL Rx only	Atlantic Biologicals Corp.	2026-08-07	HUMAN PRESCRIPTION DRUG LABEL	2