Home NDC 0406-3243 Hydromorphone Hydrochloride
Product NDC 0406-3243
11-digit product format 004063243
Labeler code 0406
Product ID 0406-3243_8c16f6cf-c3d2-458c-9cd1-4fddd7c473a8
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 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 1 .
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.
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 2026-08-01 22:54:32 2026-06 A076855-001 HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB 2004-12-23 a50c72e98297…2026-08-01 22:54:32 2026-06 A076855-002 HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB 2007-09-19 a50c72e98297…2026-08-01 22:54:32 2026-06 A076855-003 HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB 2007-09-19 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 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 0406-3243-01 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 [STAT RX USA LLC] 2 HYDROMORPHONE ACTIVE MOIETY Q812464R06 HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 2 HYDROMORPHONE HYDROCHLORIDE ACTIVE INGREDIENT L960UP2KRW HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 HYDROMORPHONE HYDROCHLORIDE ACTIVE INGREDIENT L960UP2KRW HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYDROMORPHONE ACTIVE MOIETY Q812464R06 HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 HYDROMORPHONE ACTIVE MOIETY Q812464R06 HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 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 0406-3243 HYDROMORPHONE HYDROCHLORIDE TABLET [SPECGX LLC] 28 Current NDC, Legacy NDC, 1 package rows 20250412_4c5c1cc8-c42b-46e3-ad68-8e22f57101f2.zip
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 0406-3243-01 00406324301 100 TABLET in 1 BOTTLE (0406-3243-01) 100 tablet 2004-12-23 0000-00-00 No No Current