Home NDC 0121-0825-04 Morphine Sulfate
Product NDC 0121-0825
Requested package NDC 0121-0825-04
11-digit product format 001210825
Labeler code 0121
Product ID 0121-0825_fb581fb2-a860-4eb7-a222-9ee0db19e178
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MORPHINE SULFATE
Dosage form SOLUTION
Route ORAL
Labeler PAI
Application ANDA206573
Marketing category ANDA
Marketing start 2016-11-14
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 2023-12-31
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0121-0825 0121-0825-04 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A206573-001 MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 A206573-002 MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2023-09-12
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 · 61 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 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2023-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2023-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2023-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2023-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2023-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2023-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2023-09-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2023-09-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2023-09-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2016-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2023-09-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2023-09-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2023-09-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2023-09-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206573-002 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2023-09-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206573-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2016-11-14 b00525d2431f…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 47 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0825 MORPHINE SULFATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 17 Legacy NDC 20250507_9405556c-20e0-4e47-b1b0-7872bcc6517e.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0121-0825-04 00121082504 118 mL in 1 BOTTLE (0121-0825-04) 118 ml 2016-11-14 0000-00-00 No No Current