Morphine Sulfate
- Product NDC
- 0054-0404
- Requested package NDC
- 0054-0404-50
- 11-digit product format
- 000540404
- Labeler code
- 0054
- Product ID
- 0054-0404_ca359246-4674-4b32-b8b2-673d32b7112f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA022195
- Marketing category
- NDA
- Marketing start
- 2008-03-17
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0054-0404 | 0054-0404-50 | D | Discontinued by firm | 2026-08-11 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022195-001 | MORPHINE SULFATE | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 |
| N022195-002 | MORPHINE SULFATE | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 |
| N022195-003 | MORPHINE SULFATE | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022195-001 | AA |
| N022195-002 | AA |
| N022195-003 | 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.
| 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 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | RLD | 2008-03-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022195-002 | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022195-003 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-01-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022195-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | RLD | 2008-03-17 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022195-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022195-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022195-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022195-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022195-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022195-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022195-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022195-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022195-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022195-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022195-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022195-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022195-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022195-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022195-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022195-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022195-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022195-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022195-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022195-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022195-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022195-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022195-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022195-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022195-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022195-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022195-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022195-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022195-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022195-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022195-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022195-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022195-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022195-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022195-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022195-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022195-002 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022195-003 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022195-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022195-002 | AA | 1 | 8072bd15b7f6… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022195-001 | NPP | 2024-06-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022195-002 | NPP | 2024-06-02 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022195-001 | NPP | 2024-06-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022195-002 | NPP | 2024-06-02 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022195-001 | NPP | 2024-06-02 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022195-002 | NPP | 2024-06-02 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022195-001 | NPP | 2024-06-02 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022195-002 | NPP | 2024-06-02 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022195-001 | NPP | 2024-06-02 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022195-002 | NPP | 2024-06-02 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022195-001 | NPP | 2024-06-02 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022195-002 | NPP | 2024-06-02 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022195-001 | NPP | 2024-06-02 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022195-002 | NPP | 2024-06-02 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022195-001 | NPP | 2024-06-02 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022195-002 | NPP | 2024-06-02 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022195-001 | NPP | 2024-06-02 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022195-002 | NPP | 2024-06-02 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022195-001 | NPP | 2024-06-02 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022195-002 | NPP | 2024-06-02 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022195-001 | NPP | 2024-06-02 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022195-002 | NPP | 2024-06-02 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022195-001 | NPP | 2024-06-02 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022195-002 | NPP | 2024-06-02 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N022195-001 | NPP | 2024-06-02 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022195-002 | NPP | 2024-06-02 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022195-001 | NPP | 2024-06-02 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022195-002 | NPP | 2024-06-02 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022195-001 | NPP | 2024-06-02 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022195-002 | NPP | 2024-06-02 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022195-001 | NPP | 2024-06-02 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N022195-002 | NPP | 2024-06-02 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022195-001 | NPP | 2024-06-02 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N022195-002 | NPP | 2024-06-02 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022195-001 | NPP | 2024-06-02 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022195-002 | NPP | 2024-06-02 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022195-001 | NPP | 2024-06-02 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022195-002 | NPP | 2024-06-02 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022195-001 | NPP | 2024-06-02 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022195-002 | NPP | 2024-06-02 | a67488948f0b… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 89941d4c-522d-cee0-b273-43cfa7ef6d35 | Product name | 4 | 20250516 |
| f15f9e76-db42-8a50-218a-5ef5affa58da | Product name | 4 | 20240216 |
| 944b0689-73f4-6a2f-c654-1180896353c0 | Product name | 4 | 20220210 |
| 67e166c6-23d4-4709-b77d-5ca6182dcae0 | Product name | 1 | 20180830 |
| c573a64c-fe17-2eac-fbcb-788868b4ff6b | Product name | 9 | 20180619 |
| 7c1819cf-69a0-41dc-aeaa-a820729bc959 | Product name | 1 | 20170406 |
| 7a68fc31-10e5-df04-67e0-3a613a2d4d2e | Product name | 5 | 20161114 |
| 175682a8-c657-45a2-9dfb-c565306b03c8 | Product name | 1 | 20160112 |
| b73dadd0-1b4a-4f88-956f-a2be216c8fad | Product name | 1 | 20151123 |
| 4c272b1c-87fc-ebc0-994d-ac28b1e0416e | Product name | 1 | 20140508 |
| 7a537f54-d322-5e54-a3a2-035d3e21c3c6 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0054-0404-41 | Morphine Sulfate | 15 mL in 1 BOTTLE | SOLUTION | 15 | 4 | |
| 0054-0404-44 | Morphine Sulfate | 30 mL in 1 BOTTLE | SOLUTION | 30 | 4 | |
| 0054-0404-50 | Morphine Sulfate | 120 mL in 1 BOTTLE | SOLUTION | 120 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0054-0404-41 | ML - Milliliter | 0054-0404 | df083984-2fc2-4a48-aa16-7a3c942ec370 | 1 | 2012-07-24 |
| 0054-0404-44 | ML - Milliliter | 0054-0404 | 3c370735-f78a-4ca0-93ca-48deeae62301 | 1 | 2012-07-24 |
| 0054-0404-50 | ML - Milliliter | 0054-0404 | 01c8468f-6136-4b82-bc39-e6ee845f1afd | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | 6654b91e-3b3f-4062-ac65-a2a70f942da4 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 022195 NDA022195 |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | bb6b3439-9f0c-45f5-bf6f-c7a971af0a8f | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 022195 NDA022195 |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | 76966c05-df75-4072-ae99-97e42f91ab75 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 022195 NDA022195 |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | 67f0ee8d-696e-4c08-9007-3df0e3988bad | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 022195 NDA022195 |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose Inc. | 8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | 022195 NDA022195 |
| Morphine Sulfate | MORPHINE SULFATE | Hikma Pharmaceuticals USA Inc. | ca359246-4674-4b32-b8b2-673d32b7112f | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | 022195 NDA022195 0054-0404-50 0054-0404 00054040450 |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | ae57637e-a86a-4ea5-9c68-47d98153d41a | 2026-01-31 | Boxed warning, Warnings, Adverse reactions | 022195 NDA022195 |
| Morphine Sulfate | MORPHINE SULFATE | American Health Packaging | 9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | 022195 NDA022195 |
| Morphine Sulfate | MORPHINE SULFATE | PAI Holdings, LLC dba PAI Pharma | 6e32b869-31c7-48c1-98ae-b21bd28151d7 | 2024-11-19 | Boxed warning, Warnings, Adverse reactions | 022195 NDA022195 |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | cc50d3c1-b4c8-4edc-9aa0-844d2fed45fb | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | 022195 NDA022195 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 892589 | morphine sulfate 10 MG in 5 mL Oral Solution | PSN | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892625 | morphine sulfate 20 MG in 1 mL Concentrate for Oral Solution | PSN | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 894780 | morphine sulfate 20 MG in 5 mL Oral Solution | PSN | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892589 | morphine sulfate 2 MG/ML Oral Solution | SCD | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892625 | morphine sulfate 20 MG/ML Oral Solution | SCD | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 894780 | morphine sulfate 4 MG/ML Oral Solution | SCD | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892625 | morphine sulfate 10 MG per 0.5 ML Concentrate for Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892589 | morphine sulfate 10 MG per 5 ML Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892625 | morphine sulfate 100 MG per 5 ML Concentrate for Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 894780 | morphine sulfate 20 MG per 5 ML Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892625 | morphine sulfate 20 MG/ML Concentrate for Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892589 | MS 2 MG/ML Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892625 | MS 20 MG/ML Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 894780 | MS 4 MG/ML Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0054-0404-50 | 00054040450 | 120 mL in 1 BOTTLE (0054-0404-50) | 120 ml | 2010-01-25 | 0000-00-00 | No | No | Current |