Home NDC 13107-107 HYDROMORPHONE HYDROCHLORIDE
Product NDC 13107-107
11-digit product format 131070107
Labeler code 13107
Product ID 13107-107_1c45740c-5fb6-4cf7-81b9-0865717334e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROMORPHONE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA205814
Marketing category ANDA
Marketing start 2016-05-17
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 A205814-001 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 A205814-002 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 A205814-003 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13
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 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205814-002 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2016-05-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205814-003 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2016-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205814-001 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2016-05-13 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 13107-107-01 HYDROMORPHONE HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 7 13107-107-05 HYDROMORPHONE HYDROCHLORIDE 500 in 1 BOTTLE TABLET 500 7 13107-107-20 HYDROMORPHONE HYDROCHLORIDE 20 in 1 BOTTLE TABLET 20 7 13107-107-99 HYDROMORPHONE HYDROCHLORIDE 1000 in 1 BOTTLE TABLET 1000 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-107 HYDROMORPHONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] 7 Current NDC, Legacy NDC, 4 package rows 20240706_f778dfab-e109-428e-b1b7-4dfb1b8293e4.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13107-107-01 13107010701 100 TABLET in 1 BOTTLE (13107-107-01) 100 tablet 2016-05-17 0000-00-00 No No Current 13107-107-05 13107010705 500 TABLET in 1 BOTTLE (13107-107-05) 500 tablet 2016-05-17 0000-00-00 No No Current 13107-107-20 13107010720 20 TABLET in 1 BOTTLE (13107-107-20) 20 tablet 2016-05-17 0000-00-00 No No Current 13107-107-99 13107010799 1000 TABLET in 1 BOTTLE (13107-107-99) 1000 tablet 2016-05-17 0000-00-00 No No Current