apomorphine hydrocloride

Product NDC: 52817-720
11-digit product format: 528170720
Labeler code: 52817
Product ID: 52817-720_2fbd7414-f94f-4e18-8d0e-3ae69a5449f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: APOMORPHINE HYDROCHLORIDE
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: TruPharma, LLC
Application: ANDA212025
Marketing category: ANDA
Marketing start: 2022-02-24
Substance: APOMORPHINE HYDROCHLORIDE
Active strength: 30 mg/3mL
Pharmacologic classes: Dopamine Agonists [MoA], Dopaminergic Agonist [EPC]
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
A212025-001	APOMORPHINE HYDROCHLORIDE	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP		2022-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212025-001	AP

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 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	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212025-001	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2022-02-23	`a50c72e98297…`

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	A212025-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212025-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212025-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212025-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212025-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212025-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212025-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212025-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212025-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212025-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212025-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212025-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212025-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212025-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212025-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212025-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212025-001	AP	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212025-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212025-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212025-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212025-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212025-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212025-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212025-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212025-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212025-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212025-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212025-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212025-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212025-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212025-001	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212025-001	CGT	2022-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212025-001	CGT	2022-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212025-001	CGT	2022-08-24	`4b0b4de00fa7…`
2023-01-26 05:58 UTC	2023-01	A212025-001	CGT	2022-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212025-001	CGT	2022-08-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212025-001	CGT	2022-08-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212025-001	CGT	2022-08-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212025-001	CGT	2022-08-24	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: apomorphine hydrocloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
APOMORPHINE HYDROCHLORIDE	30 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F39049Y068	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855856	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
aedf70e4-1949-44bc-bf1b-0f282c4f0705	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8cacec2b-1363-4e94-885c-4189d5e7208a	Product name	1	20251117
d7fea1a2-3459-27e8-1231-1b79988f4937	Product name	2	20221207
3a53909e-cbfb-4956-984e-a33101906fd9	Product name	1	20201021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52817-720-01	apomorphine hydrocloride	3 mL in 1 CARTRIDGE	INJECTION	3		1
52817-720-05	apomorphine hydrocloride	5 in 1 CARTON	INJECTION	5		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52817-720-01	ML - Milliliter	52817-720	d44b4ba3-5faf-4db9-97e2-8889ef8b37dc	1	2022-03-09
52817-720-05	ML - Milliliter	52817-720	c4ace5b2-bf2d-498c-bfbd-1ed7d02a32b2	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52817-720	APOMORPHINE HYDROCLORIDE (APOMORPHINE HYDROCHLORIDE) INJECTION [TRUPHARMA, LLC]	1	Current NDC, Legacy NDC, 2 package rows	20220226_aedf70e4-1949-44bc-bf1b-0f282c4f0705.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
apomorphine hydrocloride	APOMORPHINE HYDROCHLORIDE	TruPharma, LLC	aedf70e4-1949-44bc-bf1b-0f282c4f0705	2022-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212025 application number: ANDA212025 ndc (product): 52817-720

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F39049Y068	APOMORPHINE HYDROCHLORIDE	41372-20-7	APOMORPHINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855856	apomorphine HCl 30 MG in 3 mL Cartridge	PSN	aedf70e4-1949-44bc-bf1b-0f282c4f0705	1
855856	3 ML apomorphine hydrochloride 10 MG/ML Cartridge	SCD	aedf70e4-1949-44bc-bf1b-0f282c4f0705	1
855856	apomorphine HCl 30 MG per 3 ML Cartridge	SY	aedf70e4-1949-44bc-bf1b-0f282c4f0705	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52817-720-01	52817072001	3 mL in 1 CARTRIDGE	3 ml					Historical
52817-720-05	52817072005	5 CARTRIDGE in 1 CARTON (52817-720-05) / 3 mL in 1 CARTRIDGE (52817-720-01)	5 cartridge	2022-02-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
apomorphine hydrocloride	TruPharma, LLC \| Berkshire Sterile Manufacturing \| Macfarlan Smith Limited	2022-02-24	HUMAN PRESCRIPTION DRUG LABEL	1