Dicyclomine Hydrochloride
- Product NDC
- 0591-0795
- 11-digit product format
- 005910795
- Labeler code
- 0591
- Product ID
- 0591-0795_cdc9e5f4-36d9-40dc-894f-2d8682e4a61b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA085223
- Marketing category
- ANDA
- Marketing start
- 1986-07-30
- 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 |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 0591-0795 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-17 | ||
| unfinished package | package | 0591-0795 | 0591-0795-00 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-17 | |
| unfinished package | package | 0591-0795 | 0591-0795-77 | UNFINISHED | Active or certified unfinished drug listing | 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 0591-0795-00 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 0591-0795-00 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 0591-0795-00 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 0591-0795-00 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 0591-0795-00 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 0591-0795-00 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 0591-0795-00 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 0591-0795-00 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 0591-0795-00 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 0591-0795-00 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 0591-0795-00 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 0591-0795-00 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 0591-0795-00 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 0591-0795-00 | 50b4072663b7… | eae3003ed65e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A085223-001 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A085223-001 | 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 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1986-07-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1986-07-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1986-07-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1986-07-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A085223-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | RS | 1986-07-30 | 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 | A085223-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A085223-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085223-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A085223-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085223-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085223-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085223-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085223-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085223-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085223-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A085223-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085223-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085223-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085223-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A085223-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A085223-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A085223-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A085223-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A085223-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A085223-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A085223-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A085223-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A085223-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A085223-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A085223-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A085223-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A085223-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A085223-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A085223-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A085223-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A085223-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A085223-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A085223-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A085223-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A085223-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A085223-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A085223-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A085223-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A085223-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A085223-001 | 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 |
|---|---|
| a5937c7b-cdfc-46e6-a0fa-541b24f91d47 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0591-0795-01 | Dicyclomine Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 20 | |
| 0591-0795-10 | Dicyclomine Hydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 20 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-0795-01 | EA - Each | 0591-0795 | 17987d0c-ae3a-42a7-8391-c77a3e6ad7f7 | 1 | 2012-07-24 |
| 0591-0795-10 | EA - Each | 0591-0795 | 9c750ecb-c939-4704-b27a-f68c901f22e8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Northwind Health Company, LLC | c195b8ea-c1bf-453f-e053-2a95a90a2121 | 2026-01-01 | Warnings, Adverse reactions | 085223 ANDA085223 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | da0e1f63-cb90-4c2a-908f-7d81e672be10 | 2025-01-07 | Warnings, Adverse reactions | 085223 ANDA085223 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 517646d8-366e-5cf2-e054-00144ff88e88 | 2024-07-08 | Warnings, Adverse reactions | 085223 ANDA085223 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Actavis Pharma, Inc. | a5937c7b-cdfc-46e6-a0fa-541b24f91d47 | 2024-04-01 | Warnings, Adverse reactions | 085223 ANDA085223 0591-0795 |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Proficient Rx LP | bd8b7fcd-04f4-4d1c-aa27-743aaf4c2876 | 2022-03-01 | Warnings, Adverse reactions | 085223 ANDA085223 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | da0e1f63-cb90-4c2a-908f-7d81e672be10 | 32 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | da0e1f63-cb90-4c2a-908f-7d81e672be10 | 32 |
| 991061 | dicyclomine HCl 10 MG Oral Capsule | PSN | 8b242ad1-0438-42ed-931b-8f85ea9bc660 | 28 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | 8b242ad1-0438-42ed-931b-8f85ea9bc660 | 28 |
| 991061 | dicyclomine hydrochloride 10 MG Oral Capsule | SCD | 8b242ad1-0438-42ed-931b-8f85ea9bc660 | 28 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | 8b242ad1-0438-42ed-931b-8f85ea9bc660 | 28 |
| 991061 | dicyclomine HCl 10 MG Oral Capsule | PSN | a5937c7b-cdfc-46e6-a0fa-541b24f91d47 | 20 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | a5937c7b-cdfc-46e6-a0fa-541b24f91d47 | 20 |
| 991061 | dicyclomine hydrochloride 10 MG Oral Capsule | SCD | a5937c7b-cdfc-46e6-a0fa-541b24f91d47 | 20 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | a5937c7b-cdfc-46e6-a0fa-541b24f91d47 | 20 |
| 991061 | dicyclomine HCl 10 MG Oral Capsule | PSN | 7cbefee1-1b23-4e9b-8527-ec357a9dbcb6 | 8 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | 7cbefee1-1b23-4e9b-8527-ec357a9dbcb6 | 8 |
| 991061 | dicyclomine hydrochloride 10 MG Oral Capsule | SCD | 7cbefee1-1b23-4e9b-8527-ec357a9dbcb6 | 8 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | 7cbefee1-1b23-4e9b-8527-ec357a9dbcb6 | 8 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | 41d74ebf-7775-0f7f-e054-00144ff8d46c | 7 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | 41d74ebf-7775-0f7f-e054-00144ff8d46c | 7 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | ebaf5799-80f9-4e16-9e11-99eaf30531f4 | 5 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | b90756d4-db4b-496b-9ad1-12978bdc3d3d | 5 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | 517646d8-366e-5cf2-e054-00144ff88e88 | 5 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | ebaf5799-80f9-4e16-9e11-99eaf30531f4 | 5 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | 517646d8-366e-5cf2-e054-00144ff88e88 | 5 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | b90756d4-db4b-496b-9ad1-12978bdc3d3d | 5 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | c195b8ea-c1bf-453f-e053-2a95a90a2121 | 4 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | 27c67441-0e12-47e9-9157-26af00065a0e | 4 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | bd8b7fcd-04f4-4d1c-aa27-743aaf4c2876 | 4 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | bd8b7fcd-04f4-4d1c-aa27-743aaf4c2876 | 4 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | c195b8ea-c1bf-453f-e053-2a95a90a2121 | 4 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | 27c67441-0e12-47e9-9157-26af00065a0e | 4 |
| 991061 | dicyclomine HCl 10 MG Oral Capsule | PSN | 59ca0395-599b-0d7e-e053-2a91aa0a2c91 | 1 |
| 991061 | dicyclomine HCl 10 MG Oral Capsule | PSN | f325dd3d-8ebe-4aa3-8c45-43438c75defe | 1 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | e576f409-d319-4878-9863-25988be7fde1 | 1 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | 59ca0395-599b-0d7e-e053-2a91aa0a2c91 | 1 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | f325dd3d-8ebe-4aa3-8c45-43438c75defe | 1 |
| 991061 | dicyclomine hydrochloride 10 MG Oral Capsule | SCD | 59ca0395-599b-0d7e-e053-2a91aa0a2c91 | 1 |
| 991061 | dicyclomine hydrochloride 10 MG Oral Capsule | SCD | f325dd3d-8ebe-4aa3-8c45-43438c75defe | 1 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | 59ca0395-599b-0d7e-e053-2a91aa0a2c91 | 1 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | e576f409-d319-4878-9863-25988be7fde1 | 1 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | f325dd3d-8ebe-4aa3-8c45-43438c75defe | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0591-0795-00 | 00591079500 | 62500 TABLET in 1 BOX (0591-0795-00) | 62500 tablet | 04-JAN-24 | Current | |||
| 0591-0795-01 | 00591079501 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-0795-01) | 100 tablet | 1986-07-30 | 0000-00-00 | No | No | Current |
| 0591-0795-10 | 00591079510 | 1000 TABLET in 1 BOTTLE, PLASTIC (0591-0795-10) | 1000 tablet | 1986-07-30 | 0000-00-00 | No | No | Current |
| 0591-0795-77 | 00591079577 | 75000 TABLET in 1 CONTAINER (0591-0795-77) | 75000 tablet | 23-JAN-26 | Current |