Home NDC 75826-129 Morphine Sulfate
Product NDC 75826-129
11-digit product format 758260129
Labeler code 75826
Product ID 75826-129_2b0eba4c-7f43-72ef-e063-6294a90afd7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form SOLUTION
Route ORAL
Labeler Winder Laboratories LLC
Application ANDA211454
Marketing category ANDA
Marketing start 2019-05-15
Substance MORPHINE SULFATE
Active strength 10 mg/5mL
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 A211454-001 MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 A211454-002 MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 A211454-003 MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12
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 3 · 102 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 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2021-02-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2021-02-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2021-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211454-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA 2021-02-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211454-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2021-02-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211454-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2021-02-12 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 51 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Morphine Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MORPHINE SULFATE 10 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X3P646A2J0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 892589 Internal RxNorm lookup 892625 Internal RxNorm lookup 894780 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 75826-129-05 Morphine Sulfate 100 mL in 1 BOTTLE, PLASTIC SOLUTION 100 8 75826-129-17 Morphine Sulfate 500 mL in 1 BOTTLE, PLASTIC SOLUTION 500 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75826-129 MORPHINE SULFATE SOLUTION [WINDER LABORATORIES LLC] 8 Current NDC, Legacy NDC, 2 package rows 20250109_e9a7319a-bf1f-48db-a71e-6d4e6ead9555.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 75826-129-05 75826012905 100 mL in 1 BOTTLE, PLASTIC (75826-129-05) 100 ml 2019-05-15 0000-00-00 No No Current 75826-129-10 75826012910 100 mL in 1 BOTTLE, PLASTIC (75826-129-10) 100 ml 2021-02-25 0000-00-00 No No Current 75826-129-17 75826012917 500 mL in 1 BOTTLE, PLASTIC (75826-129-17) 500 ml 2019-05-15 0000-00-00 No No Current 75826-129-50 75826012950 500 mL in 1 BOTTLE, PLASTIC (75826-129-50) 500 ml 2021-02-25 0000-00-00 No No Current