Home NDC 0406-8003 Morphine Sulfate
Product NDC 0406-8003
11-digit product format 004068003
Labeler code 0406
Product ID 0406-8003_852596c9-601f-477c-9966-580f728d9e54
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name morphine sulfate
Dosage form SOLUTION
Route ORAL
Labeler SpecGx LLC
Application ANDA202348
Marketing category ANDA
Marketing start 2011-07-15
Substance MORPHINE SULFATE
Active strength 20 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202348-001 MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202348-001 AA
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 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202348-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2011-07-15 e64feba35796…
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 20 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 892625 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] 10 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] 10 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] 10 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] 10 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] 10 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] 10 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] 10 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] 10 WATER INACTIVE INGREDIENT 059QF0KO0R MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-8003 MORPHINE SULFATE SOLUTION [SPECGX LLC] 26 Current NDC, Legacy NDC, 8 package rows 20240724_242c2512-1d49-486b-a9c3-6905f667799e.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 0406-8003-12 00406800312 6 CARTON in 1 CASE (0406-8003-12) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC 6 carton 2011-07-15 0000-00-00 No No Current 0406-8003-15 00406800315 6 CARTON in 1 CASE (0406-8003-15) / 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC 6 carton 2011-07-15 0000-00-00 No No Current 0406-8003-24 00406800324 6 CARTON in 1 CASE (0406-8003-24) / 1 BOTTLE, PLASTIC in 1 CARTON / 240 mL in 1 BOTTLE, PLASTIC 6 carton 2011-07-15 0000-00-00 No No Current 0406-8003-30 00406800330 6 CARTON in 1 CASE (0406-8003-30) / 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC 6 carton 2011-07-15 0000-00-00 No No Current