Home NDC 27505-006-05 ONAPGO
Product NDC 27505-006
Requested package NDC 27505-006-05
11-digit product format 275050006
Labeler code 27505
Product ID 27505-006_5d1a7807-f580-a7f3-e063-6294a90aad57
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Apomorphine hydrochloride
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc
Application NDA214056
Marketing category NDA
Marketing start 2025-02-04
Substance APOMORPHINE HYDROCHLORIDE
Active strength 4.9 mg/mL
Pharmacologic classes Dopamine Agonists [MoA], Dopaminergic Agonist [EPC]
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 N214056-001 ONAPGO APOMORPHINE HYDROCHLORIDE 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214056-001 NP 2028-02-03
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 RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N214056-001 ONAPGO 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214056-001 ONAPGO 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214056-001 ONAPGO 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214056-001 ONAPGO 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214056-001 ONAPGO 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214056-001 ONAPGO 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214056-001 ONAPGO 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 N214056-001 NP 2028-02-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214056-001 NP 2028-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214056-001 NP 2028-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214056-001 NP 2028-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214056-001 NP 2028-02-03 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214056-001 NP 2028-02-03 a50c72e98297…
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 ONAPGO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength APOMORPHINE HYDROCHLORIDE 4.9 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 27505-006-01 ONAPGO 20 mL in 1 CARTRIDGE INJECTION, SOLUTION 20 16 27505-006-05 ONAPGO 5 in 1 CARTON INJECTION, SOLUTION 5 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27505-006 ONAPGO (APOMORPHINE HYDROCHLORIDE) INJECTION, SOLUTION [MDD US OPERATIONS, LLC, A SUBSIDIARY OF SUPERNUS PHARMACEUTICALS, INC] 8 Current NDC, 2 package rows 20250328_f3552b6e-5ae7-4993-aa1a-e399c4a7080a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 27505-006-05 27505000605 5 CARTRIDGE in 1 CARTON (27505-006-05) / 20 mL in 1 CARTRIDGE (27505-006-01) 5 cartridge 2025-02-04 No No Current