Home NDC 43602-002 HYDROMORPHONE HYDROCHLORIDE
Product NDC 43602-002
11-digit product format 436020002
Labeler code 43602
Product ID 43602-002_b492adee-8ae4-476e-8047-c13fb2136b58
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydromorphone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Ascent Pharmaceuticals Inc
Application ANDA210506
Marketing category ANDA
Marketing start 2018-01-24
Substance HYDROMORPHONE HYDROCHLORIDE
Active strength 2 mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210506-001 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 A210506-002 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 A210506-003 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 129 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 2026-09-14 22:38:34 2026-08 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210506-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2018-01-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210506-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2018-01-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210506-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2018-01-17 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
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 HYDROMORPHONE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROMORPHONE HYDROCHLORIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L960UP2KRW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 897696 Internal RxNorm lookup 897702 Internal RxNorm lookup 897710 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43602-002-05 HYDROMORPHONE HYDROCHLORIDE 500 in 1 BOTTLE TABLET 500 1 43602-002-30 HYDROMORPHONE HYDROCHLORIDE 30 in 1 BOTTLE TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43602-002 HYDROMORPHONE HYDROCHLORIDE TABLET [ASCENT PHARMACEUTICALS INC] 1 Current NDC, 2 package rows 20240906_4de15afe-d676-4faa-a34d-9b9cb20dbf54.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43602-002-05 43602000205 500 TABLET in 1 BOTTLE (43602-002-05) 500 tablet 2018-01-24 No No Current 43602-002-30 43602000230 30 TABLET in 1 BOTTLE (43602-002-30) 30 tablet 2018-01-24 No No Current