Loperamide Hydrochloride
- Product NDC
- 66267-132
- 11-digit product format
- 662670132
- Labeler code
- 66267
- Product ID
- 66267-132_1f93b346-5041-b800-e063-6294a90af72d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA073192
- Marketing category
- ANDA
- Marketing start
- 1993-05-01
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|
| 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 | 66267-132-20 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 66267-132-18 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 66267-132-60 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 66267-132-12 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 66267-132-15 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 66267-132-20 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 66267-132-18 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 66267-132-60 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 66267-132-12 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 66267-132-15 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 66267-132-20 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 66267-132-18 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 66267-132-60 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 66267-132-12 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 66267-132-15 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 66267-132-20 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 66267-132-18 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 66267-132-60 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 66267-132-12 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 66267-132-15 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A073192-001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A073192-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A073192-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A073192-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A073192-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073192-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A073192-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073192-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073192-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073192-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073192-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073192-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073192-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A073192-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073192-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073192-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073192-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A073192-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073192-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A073192-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A073192-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A073192-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A073192-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A073192-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A073192-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A073192-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A073192-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A073192-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A073192-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A073192-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A073192-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A073192-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A073192-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A073192-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A073192-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A073192-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A073192-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A073192-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A073192-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A073192-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A073192-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A073192-001 | AB | 1 | f41ea6bd6efb… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loperamide Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LOPERAMIDE HYDROCHLORIDE | 2 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 77TI35393C | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 978006 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3e898141-8d40-49f1-e054-00144ff88e88 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 10f838ef-a72b-645d-80f8-e2255205c3b1 | Product name | 6 | 20240805 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 66267-132-12 | 2024-08-13 | LOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only |
| 66267-132-15 | 2024-08-13 | LOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only |
| 66267-132-18 | 2024-08-13 | LOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only |
| 66267-132-20 | 2024-08-13 | LOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only |
| 66267-132-60 | 2024-08-13 | LOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only |
| 66267-132-12 | 2023-01-30 | LOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only |
| 66267-132-15 | 2023-01-30 | LOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only |
| 66267-132-18 | 2023-01-30 | LOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only |
| 66267-132-20 | 2023-01-30 | LOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only |
| 66267-132-60 | 2023-01-30 | LOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66267-132-12 | Loperamide Hydrochloride | 12 in 1 BOTTLE | CAPSULE | 12 | 6 | |
| 66267-132-15 | Loperamide Hydrochloride | 15 in 1 BOTTLE | CAPSULE | 15 | 6 | |
| 66267-132-18 | Loperamide Hydrochloride | 18 in 1 BOTTLE | CAPSULE | 18 | 6 | |
| 66267-132-20 | Loperamide Hydrochloride | 20 in 1 BOTTLE | CAPSULE | 20 | 6 | |
| 66267-132-60 | Loperamide Hydrochloride | 15 in 1 BOTTLE | CAPSULE | 15 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66267-132-12 | EA - Each | 66267-132 | fd360286-e6a1-4e45-be31-3b2de61cc8f0 | 1 | 2016-11-08 |
| 66267-132-20 | EA - Each | 66267-132 | ce27e4ac-945d-4dc0-ba34-0f50cf65de7b | 1 | 2016-11-08 |
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 |
|---|---|---|---|---|---|---|
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | Cardinal Health 107, LLC | ca8de42f-8aea-4e35-ab3a-75ecea718f4f | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 45a1e6b0-1e2b-958a-e063-6394a90a261d | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | American Health Packaging | 42989f90-8ff5-44d1-a462-28c18ce02738 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3310a3c2-389a-4b27-a478-67c905789854 | 2025-10-20 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 580e6cd4-3f05-4996-9dc3-c50d757ae210 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | A-S Medication Solutions | 97c37571-9116-40d6-ba07-f4a5a8d9b689 | 2025-08-08 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | Bryant Ranch Prepack | 865cf4c7-f643-451b-b0d4-d30bda621f7d | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 3e898141-8d40-49f1-e054-00144ff88e88 | 2024-08-13 | Warnings, Adverse reactions | 073192 ANDA073192 66267-132 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | af0b886f-c065-26dc-e053-2995a90ac471 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 8bf47ac3-746f-47c3-82b2-32ac979ff963 | 2016-11-30 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 978006 | loperamide HCl 2 MG Oral Capsule | PSN | 3e898141-8d40-49f1-e054-00144ff88e88 | 6 |
| 978006 | loperamide hydrochloride 2 MG Oral Capsule | SCD | 3e898141-8d40-49f1-e054-00144ff88e88 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 66267-132-12 | 66267013212 | 12 CAPSULE in 1 BOTTLE (66267-132-12) | 12 capsule | 2016-10-10 | 0000-00-00 | No | No | Current |
| 66267-132-15 | 66267013215 | 15 CAPSULE in 1 BOTTLE (66267-132-15) | 15 capsule | 2016-10-10 | 0000-00-00 | No | No | Current |
| 66267-132-18 | 66267013218 | 18 CAPSULE in 1 BOTTLE (66267-132-18) | 18 capsule | 2016-10-10 | 0000-00-00 | No | No | Current |
| 66267-132-20 | 66267013220 | 20 CAPSULE in 1 BOTTLE (66267-132-20) | 20 capsule | 2016-10-10 | 0000-00-00 | No | No | Current |
| 66267-132-60 | 66267013260 | 15 CAPSULE in 1 BOTTLE (66267-132-60) | 15 capsule | 2017-12-28 | 0000-00-00 | No | No | Current |