Dicyclomine Hydrochloride
- Product NDC
- 50090-1577
- 11-digit product format
- 500901577
- Labeler code
- 50090
- Product ID
- 50090-1577_56ab32c8-d8a0-45a4-8338-16cf7d1d7d74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA040230
- Marketing category
- ANDA
- Marketing start
- 1999-02-26
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 50090-1577 | 50090-1577-1 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 50090-1577 | 50090-1577-3 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 50090-1577 | 50090-1577-4 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 50090-1577 | 50090-1577-5 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 50090-1577 | 50090-1577-6 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 50090-1577 | 50090-1577-7 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50090-1577-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50090-1577-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50090-1577-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50090-1577-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50090-1577-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50090-1577-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50090-1577-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50090-1577-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50090-1577-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50090-1577-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50090-1577-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50090-1577-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50090-1577-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50090-1577-7 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50090-1577-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50090-1577-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50090-1577-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50090-1577-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50090-1577-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50090-1577-7 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50090-1577-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50090-1577-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50090-1577-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50090-1577-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50090-1577-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50090-1577-7 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50090-1577-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50090-1577-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50090-1577-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50090-1577-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50090-1577-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50090-1577-7 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50090-1577-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50090-1577-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50090-1577-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50090-1577-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50090-1577-6 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50090-1577-7 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50090-1577-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50090-1577-5 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50090-1577-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50090-1577-4 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50090-1577-6 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50090-1577-7 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50090-1577-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50090-1577-5 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50090-1577-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50090-1577-4 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50090-1577-6 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50090-1577-7 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50090-1577-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50090-1577-5 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50090-1577-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50090-1577-4 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50090-1577-6 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50090-1577-7 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50090-1577-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50090-1577-5 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50090-1577-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50090-1577-4 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040230-001 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040230-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A040230-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1999-02-26 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040230-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040230-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040230-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040230-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040230-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040230-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040230-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040230-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040230-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040230-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040230-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040230-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040230-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040230-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040230-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040230-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040230-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040230-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040230-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040230-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040230-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040230-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040230-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040230-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040230-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040230-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040230-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040230-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040230-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040230-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040230-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040230-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040230-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040230-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040230-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040230-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040230-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040230-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040230-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040230-001 | AB | 1 | e64feba35796… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dicyclomine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DICYCLOMINE HYDROCHLORIDE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| CQ903KQA31 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b3c9dc85-2c6c-44f0-9c98-02673af934cb | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f755a917-03bc-45af-a1e3-50286868bfdb | Product name | 9 | 20250303 |
| f27796e1-d653-495b-932a-f51768e9be8a | Product name | 2 | 20211021 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-1577-0 | Dicyclomine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 24 | |
| 50090-1577-1 | Dicyclomine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 24 | |
| 50090-1577-2 | Dicyclomine Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | 24 | |
| 50090-1577-3 | Dicyclomine Hydrochloride | 40 in 1 BOTTLE | TABLET | 40 | 24 | |
| 50090-1577-4 | Dicyclomine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 24 | |
| 50090-1577-5 | Dicyclomine Hydrochloride | 4 in 1 BOTTLE | TABLET | 4 | 24 | |
| 50090-1577-6 | Dicyclomine Hydrochloride | 8 in 1 BOTTLE | TABLET | 8 | 24 | |
| 50090-1577-7 | Dicyclomine Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | 24 | |
| 50090-1577-8 | Dicyclomine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 24 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-1577-0 | EA - Each | 50090-1577 | ee75099a-b9cf-44d4-a51b-4016ef7fb2ae | 1 | 2021-09-07 |
| 50090-1577-2 | EA - Each | 50090-1577 | 7e015103-6d4c-4706-ac81-2f19f3a92d2e | 1 | 2021-09-07 |
| 50090-1577-8 | EA - Each | 50090-1577 | 1e764771-af68-4a56-b858-e911aa58231c | 1 | 2021-09-07 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-1577 | DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] | 24 | Current NDC, Legacy NDC, 9 package rows | 20240210_b3c9dc85-2c6c-44f0-9c98-02673af934cb.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 |
|---|---|---|---|---|---|---|
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Lannett Company, LLC | bd2cba10-70ec-4d1f-b46c-53d1de2ee130 | 2026-08-06 | Warnings, Adverse reactions | 040230 ANDA040230 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Bryant Ranch Prepack | 3dc0f4f0-ee38-4f9b-abb6-6395215fe524 | 2026-07-16 | Warnings, Adverse reactions | 040230 ANDA040230 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Bryant Ranch Prepack | 34db5a80-f445-41e5-b3c4-4c18abb09c92 | 2026-07-14 | Warnings, Adverse reactions | 040230 ANDA040230 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | REMEDYREPACK INC. | 7ff96d1f-fb87-4244-a697-1d93e10eb738 | 2026-07-10 | Warnings, Adverse reactions | 040230 ANDA040230 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Major Pharmaceuticals | 5eee0dff-d157-4534-adfb-c035b7042c07 | 2026-06-16 | Warnings, Adverse reactions | 040230 ANDA040230 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 6fb9d156-f321-4f7d-b308-2a0e6056fd71 | 2026-04-06 | Warnings, Adverse reactions | 040230 ANDA040230 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Northwind Health Company, LLC | da82cb46-7b4b-1ef5-e053-2a95a90ad10d | 2026-01-01 | Warnings, Adverse reactions | 040230 ANDA040230 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Proficient Rx LP | 3b7145d7-1ba7-45c1-8202-b8fc575d5a8e | 2025-06-01 | Warnings, Adverse reactions | 040230 ANDA040230 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Chartwell RX, LLC | d628ac1c-404d-45eb-8aab-0e550c95ed4a | 2024-10-10 | Warnings, Adverse reactions | 040230 ANDA040230 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 82832a91-d16c-3a63-e053-2a91aa0a3ffb | 2024-09-12 | Warnings, Adverse reactions | 040230 ANDA040230 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | American Health Packaging | 833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe8 | 2024-08-29 | Warnings, Adverse reactions | 040230 ANDA040230 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | A-S Medication Solutions | b3c9dc85-2c6c-44f0-9c98-02673af934cb | 2024-02-09 | Warnings, Adverse reactions | 040230 ANDA040230 50090-1577 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | da2c43f8-1c3a-447f-8994-f9899fb5e141 | 2018-12-20 | Warnings, Adverse reactions | 040230 ANDA040230 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 991061 | dicyclomine HCl 10 MG Oral Capsule | PSN | b3c9dc85-2c6c-44f0-9c98-02673af934cb | 24 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | b3c9dc85-2c6c-44f0-9c98-02673af934cb | 24 |
| 991061 | dicyclomine hydrochloride 10 MG Oral Capsule | SCD | b3c9dc85-2c6c-44f0-9c98-02673af934cb | 24 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | b3c9dc85-2c6c-44f0-9c98-02673af934cb | 24 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-1577-0 | 50090157700 | 30 TABLET in 1 BOTTLE (50090-1577-0) | 30 tablet | 2014-12-24 | 0000-00-00 | No | No | Current |
| 50090-1577-1 | 50090157701 | 100 TABLET in 1 BOTTLE (50090-1577-1) | 100 tablet | 2019-10-09 | 0000-00-00 | No | No | Current |
| 50090-1577-2 | 50090157702 | 20 TABLET in 1 BOTTLE (50090-1577-2) | 20 tablet | 2014-12-24 | 0000-00-00 | No | No | Current |
| 50090-1577-3 | 50090157703 | 40 TABLET in 1 BOTTLE (50090-1577-3) | 40 tablet | 2019-10-09 | 0000-00-00 | No | No | Current |
| 50090-1577-4 | 50090157704 | 60 TABLET in 1 BOTTLE (50090-1577-4) | 60 tablet | 2019-10-09 | 0000-00-00 | No | No | Current |
| 50090-1577-5 | 50090157705 | 4 TABLET in 1 BOTTLE (50090-1577-5) | 4 tablet | 2019-10-09 | 0000-00-00 | No | No | Current |
| 50090-1577-6 | 50090157706 | 8 TABLET in 1 BOTTLE (50090-1577-6) | 8 tablet | 2019-10-09 | 0000-00-00 | No | No | Current |
| 50090-1577-7 | 50090157707 | 10 TABLET in 1 BOTTLE (50090-1577-7) | 10 tablet | 2019-10-09 | 0000-00-00 | No | No | Current |
| 50090-1577-8 | 50090157708 | 90 TABLET in 1 BOTTLE (50090-1577-8) | 90 tablet | 2014-12-24 | 0000-00-00 | No | No | Current |