Diclofenac Sodium
- Product NDC
- 43063-693
- 11-digit product format
- 430630693
- Labeler code
- 43063
- Product ID
- 43063-693_7d4f5b39-d094-5353-e053-2a91aa0a8db9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 1998-11-13
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 50 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 | 43063-693 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 43063-693 | 43063-693-60 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 43063-693 | 43063-693-90 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 43063-693 | 43063-693-93 | D | Discontinued by firm | 2026-10-05 |
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 | 43063-693-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43063-693-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43063-693-93 | 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 | 43063-693-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43063-693-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43063-693-93 | 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 | 43063-693-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43063-693-90 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43063-693-93 | 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 | 43063-693-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43063-693-90 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43063-693-93 | 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 | 43063-693-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43063-693-90 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43063-693-93 | 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 | 43063-693-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43063-693-90 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43063-693-93 | 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 | 43063-693-60 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43063-693-90 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43063-693-93 | 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 | 43063-693-60 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 43063-693-90 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 43063-693-93 | 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 | 43063-693-60 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 43063-693-90 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 43063-693-93 | 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 | 43063-693-60 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 43063-693-90 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 43063-693-93 | 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 | 43063-693-60 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 43063-693-90 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 43063-693-93 | 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 | 43063-693-60 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 43063-693-90 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 43063-693-93 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075185-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | |
| A075185-002 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | |
| A075185-003 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075185-001 | AB |
| A075185-002 | AB |
| A075185-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075185-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075185-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075185-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075185-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075185-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075185-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075185-001 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43063-693-60 | EA - Each | 43063-693 | 59c64b3a-1753-4d39-a562-b9d274d99464 | 1 | 2016-09-02 |
| 43063-693-90 | EA - Each | 43063-693 | f3123e91-3724-4de1-a92f-8ebb041e6e58 | 1 | 2016-09-02 |
| 43063-693-93 | EA - Each | 43063-693 | 1d630492-9320-47f9-a8df-89509458628e | 1 | 2016-09-02 |
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 Delayed Release | DICLOFENAC SODIUM | PHOENIX RX LLC | 41472cca-278b-934b-e063-6294a90aaf5d | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Golden State Medical Supply, Inc. | 39e67a90-df3e-ad30-e063-6394a90a7a82 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Carlsbad Technology, Inc. | 363764a0-e0a8-3e3f-e063-6294a90ad672 | 2025-06-01 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Carlsbad Technology, Inc. | 40879600-ba6c-43a8-aa5d-d0d41503d593 | 2025-05-28 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium | DICLOFENAC SODIUM | RedPharm Drug, Inc. | 4ecb7bdc-4a5e-7444-e054-00144ff88e88 | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | c933eaad-ba53-4130-90db-a66f89dfc29f | 2025-03-14 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 5b4c1a15-ed93-7192-e053-2991aa0a8360 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium DR | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | d424ab84-2aaa-38a9-e053-2a95a90adde9 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium DR | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | ec06cca5-3436-10c8-e053-2995a90a4aeb | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium DR | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | af8a1392-67e8-8201-e053-2a95a90a0fce | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | ae0add8e-3a8a-4c5d-af3b-907f64211fef | 2024-10-30 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | A-S Medication Solutions | 70156824-e5dd-42b1-9b4f-a49acb28d316 | 2024-10-15 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | 2bebda5e-227e-4a49-80e3-191cfc805295 | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | 12cce748-a7de-4b1e-9603-b5c2ce12d531 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | 2b7462e6-62dc-4b08-9fbf-5858e356a7a8 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | NuCare Pharmaceuticals, Inc. | 4b44ac98-225c-1739-e054-00144ff88e88 | 2024-07-19 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 8bda6135-c957-6b4e-e053-2995a90a0cb5 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 629b77cf-f825-8640-e053-2991aa0a10a8 | 2024-06-06 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | 7bf19e84-4f75-4d5c-9927-99220c58b572 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | df5bb0e7-a3a9-4650-aae7-9a11ce615d5d | 2024-02-08 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |