Home NDC 70408-746 Morphine Sulfate Oral Solution CII
Product NDC 70408-746
11-digit product format 704080746
Labeler code 70408
Product ID 70408-746_bad0ef41-e4f5-4a4b-af96-9de08f83a612
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form SOLUTION
Route ORAL
Labeler Nostrum Laboratories, Inc.
Application ANDA201011
Marketing category ANDA
Marketing start 2016-10-06
Marketing end 0000-00-00
Substance MORPHINE SULFATE
Active strength 100 mg/5mL
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A201011-001 MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 A201011-002 MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 A201011-003 MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06
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 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201011-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL 2014-02-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201011-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201011-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2014-02-05 301d65b070ca…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.