Home NDC 0406-5119 Morphine Sulfate
Product NDC 0406-5119
11-digit product format 004065119
Labeler code 0406
Product ID 0406-5119_675ff1e4-12b4-4141-8811-ef442950ea23
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form TABLET
Route ORAL
Labeler SpecGx LLC
Application ANDA215194
Marketing category ANDA
Marketing start 2023-09-01
Substance MORPHINE 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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215194-001 MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 A215194-002 MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 42 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 2026-08-18 06:07:40 2026-07 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215194-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2023-08-21 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215194-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2023-08-21 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Morphine Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MORPHINE 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 X3P646A2J0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 892582 Internal RxNorm lookup 892672 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 0406-5119-01 Morphine Sulfate 100 in 1 BOTTLE TABLET 100 9 0406-5119-62 Morphine Sulfate 10 in 1 CARTON TABLET 10 9 0406-5119-62 Morphine Sulfate 10 in 1 BLISTER PACK TABLET 10 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-5119 MORPHINE SULFATE TABLET [SPECGX LLC] 8 Current NDC, 3 package rows 20240503_8b69f67f-30b3-4982-953e-5a4b87ec6ac6.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 Sample Exclude flag Status 0406-5119-01 00406511901 100 TABLET in 1 BOTTLE (0406-5119-01) 100 tablet 2023-09-01 No No Current 0406-5119-62 00406511962 10 BLISTER PACK in 1 CARTON (0406-5119-62) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2023-09-01 No No Current