Diclofenac Sodium and Misoprostol
- Product NDC
- 50090-4618
- 11-digit product format
- 500904618
- Labeler code
- 50090
- Product ID
- 50090-4618_f03b3383-19af-4b8f-a544-d476186549c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium and Misoprostol
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA203995
- Marketing category
- ANDA
- Marketing start
- 2016-12-01
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM; MISOPROSTOL
- Active strength
- 75 mg/1; ug/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 product | product | 50090-4618 | I | Inactivated by FDA | 2026-08-11 | ||
| excluded package | package | 50090-4618 | 50090-4618-0 | I | Inactivated by FDA | 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-4618-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-4618-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-4618-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-4618-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-4618-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-4618-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-4618-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-4618-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-4618-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-4618-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-4618-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-4618-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-4618-0 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-4618-0 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-4618-0 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | |
| A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203995-001 | AB |
| A203995-002 | AB |
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 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203995-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203995-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-25 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203995-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203995-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203995-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203995-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203995-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203995-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203995-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203995-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203995-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203995-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203995-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203995-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203995-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203995-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203995-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203995-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203995-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203995-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203995-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203995-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203995-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203995-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203995-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203995-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203995-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203995-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203995-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A203995-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203995-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203995-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203995-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A203995-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203995-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A203995-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A203995-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A203995-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A203995-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A203995-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203995-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A203995-002 | AB | 1 | 782e0a99824c… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 111d457e-3138-4512-b0ba-d0cd760c4055 | Product name | 3 | 20250225 |
| 0426261e-1bb9-b78b-abd2-80da765a7e3e | Product name | 2 | 20240513 |
| 7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7 | Product name | 5 | 20240320 |
| 73109aa8-3e7c-b7a0-fb29-6f84db91e7d9 | Product name | 3 | 20231221 |
| 0ac2f11f-f58d-baf2-71a0-680993b48a61 | Product name | 2 | 20231211 |
| 855d63c3-b090-4636-8fc7-6d39ad23c44f | Product name | 1 | 20230829 |
| bb58f410-04be-65dd-9211-e89ead899698 | Product name | 6 | 20230323 |
| 0fcbc38a-8b29-3348-1cef-5222ea53484f | Product name | 4 | 20220516 |
| c4e1eedc-aca2-4551-8382-89144ed9d049 | Product name | 3 | 20220126 |
| 8d368a34-1453-43ea-828d-0dbcd72b8794 | Product name | 8 | 20210622 |
| d6bab9d2-edce-a213-4796-226ab15472c3 | Product name | 6 | 20200616 |
| 2487e6ef-d419-42fc-aaf8-7acc805d2370 | Product name | 2 | 20170718 |
| e071c814-e5e7-e7ed-ec76-428765d9c66b | Product name | 2 | 20151120 |
| 93148e06-b8d7-4e6c-853e-62f807d17fbb | Product name | 1 | 20151014 |
| dbb00be6-fb1c-4b0a-a770-31f7e05e247e | Product name | 1 | 20150316 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4618-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f3c4-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS. DICLOFENAC SODIUM and MISOPROSTOL delayed-release tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4618-0 | Diclofenac Sodium and Misoprostol | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4618 | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS] | 4 | Legacy NDC, 1 package rows | 20210615_90d48047-37d0-4418-86b9-b7283cf46d72.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Diclofenac Sodium and Misoprostol | DICLOFENAC SODIUM AND MISOPROSTOL | Amneal Pharmaceuticals LLC | afd30051-8f59-474b-9972-962a5a871dfb | 2025-04-22 | Boxed warning, Warnings, Adverse reactions | 203995 ANDA203995 |
| Diclofenac Sodium and Misoprostol | DICLOFENAC SODIUM AND MISOPROSTOL | Bryant Ranch Prepack | d6671b66-00ad-4949-b51a-36e1130b1cb5 | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | 203995 ANDA203995 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1359105 | diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet | PSN | 90d48047-37d0-4418-86b9-b7283cf46d72 | 4 |
| 1359105 | diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet | SCD | 90d48047-37d0-4418-86b9-b7283cf46d72 | 4 |
| 1359105 | diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet | SY | 90d48047-37d0-4418-86b9-b7283cf46d72 | 4 |
| 1359105 | diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet | SY | 90d48047-37d0-4418-86b9-b7283cf46d72 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-4618-0 | 50090461800 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4618-0) | 2019-10-17 | 0000-00-00 | No | No | Current |