Diclofenac Sodium
- Product NDC
- 68151-0849
- 11-digit product format
- 681510849
- Labeler code
- 68151
- Product ID
- 68151-0849_6d9182cf-6e6b-4859-a4a5-7d5f4f6d16bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- ANDA090066
- Marketing category
- ANDA
- Marketing start
- 2015-12-21
- 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
- E
- Listing certified through
- 2018-12-31
- 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 | 68151-0849 | I | Inactivated by FDA | 2026-08-11 | ||
| excluded package | package | 68151-0849 | 68151-0849-1 | 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 68151-0849-1 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 68151-0849-1 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090066-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 |
| A090066-002 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090066-001 | AB |
| A090066-002 | 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 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 2010-12-01 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 2010-12-01 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090066-001 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090066-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2010-12-01 | 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 | A090066-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090066-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090066-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090066-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090066-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090066-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090066-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090066-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090066-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090066-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090066-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090066-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090066-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090066-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090066-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090066-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090066-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090066-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090066-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090066-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090066-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090066-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090066-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090066-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090066-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090066-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090066-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090066-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090066-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090066-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090066-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090066-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090066-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090066-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090066-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090066-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090066-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090066-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090066-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090066-002 | 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 |
| 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 |
|---|---|---|---|---|---|
| 68151-0849-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1eb7-f424-e053-dadaa90a57ce | Diclofenac Sodium Delayed-release Tablets, USP 25 mg, 50 mg and 75 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-0849-1 | Diclofenac Sodium | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-0849 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT] | 2 | Legacy NDC, 1 package rows | 20171228_e25d255d-af25-46a3-8ea9-37123e85449c.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 | DICLOFENAC SODIUM | American Health Packaging | 63c00b50-06d3-4659-81cf-be4516429e81 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 090066 ANDA090066 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Asclemed USA, Inc. | 2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 090066 ANDA090066 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | 4ee64a93-9965-47c8-be2c-14232df44b2b | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | 090066 ANDA090066 |
| Diclofenac Sodium | DICLOFENAC SODIUM | A-S Medication Solutions | 1e669fc2-69bf-4439-a336-a103e5b9cafe | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 090066 ANDA090066 |
| Diclofenac Sodium | DICLOFENAC SODIUM | A-S Medication Solutions | 8825dc2c-3497-455f-b5e1-2aa667291957 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 090066 ANDA090066 |
| Diclofenac Sodium | DICLOFENAC SODIUM | BluePoint Laboratories | feb1541a-de83-47dd-be03-c43376527318 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | 090066 ANDA090066 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Bryant Ranch Prepack | 4e97c685-628a-4b83-ba9e-2d3caf65542b | 2025-09-04 | Boxed warning, Warnings, Adverse reactions | 090066 ANDA090066 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Rising Pharma Holdings, Inc. | 3330ea92-fc9d-4541-b378-be399b0995d3 | 2025-08-05 | Boxed warning, Warnings, Adverse reactions | 090066 ANDA090066 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Bryant Ranch Prepack | af480e78-ff65-4709-af26-c430aefb77d6 | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | 090066 ANDA090066 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | b3dbd981-453c-645f-e053-2a95a90aec3c | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 090066 ANDA090066 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | 9eeb2aef-3eb1-4583-8180-d480deb3651c | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 090066 ANDA090066 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | PSN | e25d255d-af25-46a3-8ea9-37123e85449c | 2 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | SCD | e25d255d-af25-46a3-8ea9-37123e85449c | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-0849-1 | 68151084901 | 1 in 1 BLISTER PACK | Historical |