Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 0378-0415
- 11-digit product format
- 003780415
- Labeler code
- 0378
- Product ID
- 0378-0415_70e22ff5-bb2b-4a03-b0c3-63148f56f22b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diphenoxylate hydrochloride and atropine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA085762
- Marketing category
- ANDA
- Marketing start
- 1977-11-17
- Marketing end
- 2024-03-31
- Substance
- DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
- Active strength
- 3 mg/1; mg/1
- Pharmacologic classes
- Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 0378-0415 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 0378-0415 | 0378-0415-01 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 0378-0415 | 0378-0415-10 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 0378-0415 | 0378-0415-77 | 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 | 0378-0415-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0378-0415-77 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0378-0415-01 | 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 | 0378-0415-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0378-0415-77 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0378-0415-01 | 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 | 0378-0415-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0378-0415-77 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0378-0415-01 | 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 | 0378-0415-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0378-0415-77 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0378-0415-01 | 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 | 0378-0415-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0378-0415-77 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0378-0415-01 | 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 | 0378-0415-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0378-0415-77 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0378-0415-01 | 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 | 0378-0415-10 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0378-0415-77 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0378-0415-01 | 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 | 0378-0415-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0378-0415-77 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0378-0415-01 | 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 | 0378-0415-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0378-0415-77 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0378-0415-01 | 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 | 0378-0415-10 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0378-0415-77 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0378-0415-01 | 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 | 0378-0415-10 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0378-0415-77 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0378-0415-01 | 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 | 0378-0415-10 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0378-0415-77 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0378-0415-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 |
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 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A085762-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | Approved before 1982 | f41ea6bd6efb… |
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 | A085762-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A085762-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A085762-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A085762-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A085762-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A085762-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A085762-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A085762-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A085762-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A085762-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A085762-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A085762-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A085762-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A085762-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A085762-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A085762-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A085762-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A085762-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A085762-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A085762-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A085762-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A085762-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A085762-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A085762-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A085762-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A085762-001 | AA | 1 | cb3db0bc1861… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c78bd43-efb4-4aeb-b7d8-eff1532f7822 | Product name | 4 | 20250801 |
| 41231c1e-8789-4da7-ac52-77fa90a85bf5 | Product name | 2 | 20250304 |
| e77ab9a2-80cf-4832-bff0-469bbc7cbcd0 | Product name | 2 | 20250214 |
| 5f84b7a7-523a-f042-dffb-1dadcd9b2407 | Product name | 4 | 20240110 |
| 0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca | Product name | 1 | 20230719 |
| 04cd5dc0-102f-46cb-8dbc-ca38dd2628d0 | Product name | 3 | 20230317 |
| dfd25202-b8d2-4628-9213-f3e0f9eafce5 | Product name | 4 | 20210513 |
| 4199bf9b-4718-828a-6dd6-ac2fbbd61687 | Product name | 1 | 20140508 |
| 4edd8af5-cea7-ae42-8023-e91c5335db1d | Product name | 1 | 20140508 |
| d3908afb-7784-440f-c406-88294732d36a | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-0415-01 | EA - Each | 0378-0415 | a46f8bb0-9326-4512-b6ab-931fddae8d4e | 1 | 2012-07-24 |
| 0378-0415-10 | EA - Each | 0378-0415 | 06c64298-2dad-41fb-b552-9a67bef4865f | 1 | 2012-07-24 |
| 0378-0415-77 | EA - Each | 0378-0415 | 04e1e52f-438c-4e2f-a26f-8204fbf7cc15 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | 620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad | 14 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | 620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad | 14 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | 4606e3af-badc-4584-855e-3993a915467c | 12 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | 4606e3af-badc-4584-855e-3993a915467c | 12 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | 0eaf5362-9df0-40a1-af8b-84a1e65ae9cf | 8 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | 0eaf5362-9df0-40a1-af8b-84a1e65ae9cf | 8 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | 7a7ff864-f4e4-48da-94c2-6ccbc30de49c | 3 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | 7a7ff864-f4e4-48da-94c2-6ccbc30de49c | 3 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | 18a96a2c-404f-4234-adf4-6411d2877aae | 2 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | 18a96a2c-404f-4234-adf4-6411d2877aae | 2 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | 47b65bb8-8501-448c-aecd-b41c8efb4241 | 1 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | 51536429-1544-4bdd-9cf7-7753d2978841 | 1 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | 787f49c7-3726-4eee-87f0-0d6ab8fc5f3c | 1 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | 47b65bb8-8501-448c-aecd-b41c8efb4241 | 1 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | 51536429-1544-4bdd-9cf7-7753d2978841 | 1 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | 787f49c7-3726-4eee-87f0-0d6ab8fc5f3c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0378-0415-01 | 00378041501 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0415-01) | 100 tablet | 1977-11-17 | 2024-03-31 | No | No | Current |
| 0378-0415-10 | 00378041510 | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0415-10) | 1000 tablet | 1977-11-17 | 2024-03-31 | No | No | Current |
| 0378-0415-77 | 00378041577 | 90 TABLET in 1 BOTTLE, PLASTIC (0378-0415-77) | 90 tablet | 1977-11-17 | 2024-03-31 | No | No | Current |