APOKYN

Product NDC: 27505-004
11-digit product format: 275050004
Labeler code: 27505
Product ID: 27505-004_41c194a6-daa8-f307-e063-6394a90ade0d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: APOMORPHINE HYDROCHLORIDE
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: MDD US Operations, LLC
Application: NDA021264
Marketing category: NDA
Marketing start: 2004-07-02
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021264-001	APOKYN	APOMORPHINE HYDROCHLORIDE	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20
N021264-002	APOKYN	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021264-002	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.

Product history page 1 of 3 · 82 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
2026-02-19 14:30 UTC	2026-02	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`782e0a99824c…`

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	N021264-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021264-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021264-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021264-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021264-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021264-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021264-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021264-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021264-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021264-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021264-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021264-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021264-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021264-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021264-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021264-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021264-002	AP	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021264-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021264-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021264-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021264-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021264-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021264-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021264-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021264-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021264-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021264-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021264-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021264-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021264-002	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021264-002	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

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

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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27505-004-01	APOKYN	3 mL in 1 CARTRIDGE	INJECTION	3		21
27505-004-05	APOKYN	5 in 1 CARTON	INJECTION	5		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27505-004-01	ML - Milliliter	27505-004	069cd00a-7f9d-4449-bb10-827d5e0bc621	1	2012-07-24
27505-004-05	ML - Milliliter	27505-004	2ff3ccc6-8234-4336-a911-cd8f5a43774e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
APOMORPHINE HYDROCHLORIDE	ACTIVE INGREDIENT	F39049Y068	APOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]	4
APOMORPHINE	ACTIVE MOIETY	N21FAR7B4S	APOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]	4
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	APOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]	4
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	APOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]	4
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	APOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]	4
sodium metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	APOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]	4
water	INACTIVE INGREDIENT	059QF0KO0R	APOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27505-004	APOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [MDD US OPERATIONS, LLC]	21	Current NDC, Legacy NDC, 2 package rows	20241012_3235535d-9ef9-4657-8b2a-176a807d091c.zip

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
855858	Apokyn 30 MG in 3 mL Cartridge	PSN	3235535d-9ef9-4657-8b2a-176a807d091c	21
855856	apomorphine HCl 30 MG in 3 mL Cartridge	PSN	3235535d-9ef9-4657-8b2a-176a807d091c	21
855858	3 ML apomorphine hydrochloride 10 MG/ML Cartridge [Apokyn]	SBD	3235535d-9ef9-4657-8b2a-176a807d091c	21
855856	3 ML apomorphine hydrochloride 10 MG/ML Cartridge	SCD	3235535d-9ef9-4657-8b2a-176a807d091c	21
855858	3 ML Apokyn 10 MG/ML Cartridge	SY	3235535d-9ef9-4657-8b2a-176a807d091c	21
855858	Apokyn 30 MG per 3 ML Cartridge	SY	3235535d-9ef9-4657-8b2a-176a807d091c	21
855856	apomorphine HCl 30 MG per 3 ML Cartridge	SY	3235535d-9ef9-4657-8b2a-176a807d091c	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27505-004-01	27505000401	3 mL in 1 CARTRIDGE	3 ml					Historical
27505-004-05	27505000405	5 CARTRIDGE in 1 CARTON (27505-004-05) / 3 mL in 1 CARTRIDGE (27505-004-01)	5 cartridge	2004-07-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
APOKYN	MDD US Operations, LLC \| Covance Laboratories \| Macfarlan Smith Limited \| Wickham Laboratories Limited \| Vetter Pharma Fertigung GmbH & Co. KG \| Kennet Bioservices Ltd \| A+ Secure Packaging, LLC	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	21