Home DailyMed 29cb51f9-d072-4102-9c57-e8fd1f15ee9a National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:24:29 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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 N019892-001 DILAUDID HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB RLD, RS 1992-12-07 N019892-002 DILAUDID HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB RLD 2007-11-09 N019892-003 DILAUDID HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB RLD 2007-11-09
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 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N019892-001 6589960 2020-11-09 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019892-002 6589960 2020-11-09 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019892-003 6589960 2020-11-09 Drug substance, Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N019892-001 6589960 2020-11-09 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019892-002 6589960 2020-11-09 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019892-003 6589960 2020-11-09 Drug substance, Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019892-001 6589960 2020-11-09 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019892-002 6589960 2020-11-09 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019892-003 6589960 2020-11-09 Drug substance, Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019892-001 6589960 2020-11-09 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019892-002 6589960 2020-11-09 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019892-003 6589960 2020-11-09 Drug substance, Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019892-001 6589960 2020-11-09 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019892-002 6589960 2020-11-09 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019892-003 6589960 2020-11-09 Drug substance, Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019892-001 6589960 2020-11-09 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019892-002 6589960 2020-11-09 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019892-003 6589960 2020-11-09 Drug substance, Drug product ea99ee380514…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.