Morphine Sulfate
- Product NDC
- 55700-349
- Requested package NDC
- 55700-349-60
- 11-digit product format
- 557000349
- Labeler code
- 55700
- Product ID
- 55700-349_8045940a-78db-47ac-897f-72ce63ad7cd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Quality Care Products LLC
- Application
- ANDA202104
- Marketing category
- ANDA
- Marketing start
- 2013-06-30
- Marketing end
- 0000-00-00
- Substance
- MORPHINE SULFATE
- Active strength
- 20 mg/1
- 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 | 55700-349 | 55700-349-60 | D | Discontinued by firm | 2026-08-17 |
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… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202104-001 | MORPHINE SULFATE | MORPHINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | ||
| A202104-002 | MORPHINE SULFATE | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | ||
| A202104-003 | MORPHINE SULFATE | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | ||
| A202104-004 | MORPHINE SULFATE | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | ||
| A202104-005 | MORPHINE SULFATE | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | ||
| A202104-006 | MORPHINE SULFATE | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | ||
| A202104-007 | MORPHINE SULFATE | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-06-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A202104-001 | MORPHINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202104-002 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202104-003 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202104-004 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202104-005 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202104-006 | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202104-007 | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-06-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202104-001 | MORPHINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202104-002 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202104-003 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202104-004 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202104-005 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202104-006 | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202104-007 | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-06-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202104-001 | MORPHINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202104-002 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202104-003 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202104-004 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202104-005 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202104-006 | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202104-007 | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-06-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202104-001 | MORPHINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202104-002 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202104-003 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202104-004 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202104-005 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202104-006 | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202104-007 | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-06-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202104-001 | MORPHINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202104-002 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202104-003 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202104-004 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202104-005 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202104-006 | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202104-007 | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-06-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202104-001 | MORPHINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202104-002 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202104-003 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202104-004 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202104-005 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-06-03 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202104-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202104-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202104-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202104-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202104-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202104-007 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202104-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202104-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202104-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202104-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202104-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202104-007 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202104-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202104-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202104-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202104-005 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202104-006 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202104-007 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202104-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202104-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202104-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202104-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202104-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202104-006 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202104-007 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202104-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202104-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202104-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202104-005 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202104-006 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202104-007 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202104-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202104-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202104-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202104-005 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202104-006 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202104-007 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202104-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202104-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202104-003 | AB | 1 | 87673890dc5c… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-349-30 | EA - Each | 55700-349 | 00e197b7-b28c-404b-af62-c7e4f43994a4 | 1 | 2018-03-08 |
| 55700-349-60 | EA - Each | 55700-349 | 2d06e22c-6fcf-46cd-b9b1-4f0bea7d9fe0 | 1 | 2016-05-16 |
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 | Upsher-Smith Laboratories, LLC | 97948a8f-7d1b-4614-b11d-e944cf56590b | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | 202104 ANDA202104 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55700-349-60 | 55700034960 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55700-349-60) | 2015-12-23 | 0000-00-00 | No | No | Current |