Home NDC 0054-0244 Codeine sulfate
Product NDC 0054-0244
11-digit product format 000540244
Labeler code 0054
Product ID 0054-0244_b04f74f8-d960-4b7a-988a-372d9a1e1406
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name codeine sulfate
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA022402
Marketing category NDA
Marketing start 2009-07-16
Substance CODEINE SULFATE
Active strength 30 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 N022402-001 CODEINE SULFATE CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 N022402-002 CODEINE SULFATE CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 N022402-003 CODEINE SULFATE CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16
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 · 123 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 2026-02-19 14:30 UTC 2026-02 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Codeine sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CODEINE SULFATE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 11QV9BS0CB Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997170 Internal RxNorm lookup 997287 Internal RxNorm lookup 997296 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 0054-0244-24 Codeine sulfate 10 in 1 BOX TABLET 10 25 0054-0244-24 Codeine sulfate 10 in 1 BLISTER PACK TABLET 10 25 0054-0244-25 Codeine sulfate 100 in 1 BOTTLE TABLET 100 25
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0244 CODEINE SULFATE TABLET [HIKMA PHARMACEUTICALS USA INC.] 24 Current NDC, Legacy NDC, 3 package rows 20231220_010905f9-3bcb-4b50-9fe8-a3ad0010f14c.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 Marketing end Sample Exclude flag Status 0054-0244-24 00054024424 10 BLISTER PACK in 1 BOX (0054-0244-24) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2009-07-16 0000-00-00 No No Current 0054-0244-25 00054024425 100 TABLET in 1 BOTTLE (0054-0244-25) 100 tablet 2009-07-16 0000-00-00 No No Current