Home NDC 0406-3249-01 Hydromorphone Hydrochloride
Product NDC 0406-3249
Requested package NDC 0406-3249-01
11-digit product format 004063249
Labeler code 0406
Product ID 0406-3249_914c9f88-d1ae-4b14-a18a-e1767ebb5c40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydromorphone hydrochloride
Dosage form TABLET
Route ORAL
Labeler SpecGx LLC
Application ANDA076855
Marketing category ANDA
Marketing start 2004-12-23
Substance HYDROMORPHONE HYDROCHLORIDE
Active strength 8 mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
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 44 .
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 A076855-001 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 A076855-002 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 A076855-003 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19
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 · 132 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 2026-10-15 13:18:30 2026-09 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROMORPHONE HYDROCHLORIDE 8 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 0406-3249-01 Hydromorphone Hydrochloride 100 in 1 BOTTLE TABLET 100 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROMORPHONE HYDROCHLORIDE ACTIVE INGREDIENT L960UP2KRW HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 10 HYDROMORPHONE ACTIVE MOIETY Q812464R06 HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 10 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 10 HYDROMORPHONE HYDROCHLORIDE ACTIVE INGREDIENT L960UP2KRW HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYDROMORPHONE ACTIVE MOIETY Q812464R06 HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-3249 HYDROMORPHONE HYDROCHLORIDE TABLET [SPECGX LLC] 28 Current NDC, Legacy NDC, 1 package rows 20250412_4c5c1cc8-c42b-46e3-ad68-8e22f57101f2.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 · 3 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 0406-3249-01 00406324901 100 TABLET in 1 BOTTLE (0406-3249-01) 100 tablet 2004-12-23 0000-00-00 No No Current