Home NDC 0527-1699 Codeine Sulfate
Product NDC 0527-1699
11-digit product format 005271699
Labeler code 0527
Product ID 0527-1699_aa8c1550-c22e-4945-8664-7a3d66523843
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Codeine Sulfate
Dosage form TABLET
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA203046
Marketing category ANDA
Marketing start 2014-06-13
Substance CODEINE SULFATE
Active strength 60 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 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 A203046-001 CODEINE SULFATE CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 A203046-002 CODEINE SULFATE CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 A203046-003 CODEINE SULFATE CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13
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 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 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 Codeine Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CODEINE SULFATE 60 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-1699-01 Codeine Sulfate 100 in 1 BOTTLE TABLET 100 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CODEINE SULFATE ACTIVE INGREDIENT 11QV9BS0CB CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] 6 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] 6 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1699 CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] 27 Current NDC, Legacy NDC, 1 package rows 20241105_5819bdf7-300e-45b8-8f3a-447b53656293.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 0527-1699-01 00527169901 100 TABLET in 1 BOTTLE (0527-1699-01) 100 tablet 2014-06-13 0000-00-00 No No Current