Diltiazem Hydrochloride
- Product NDC
- 10370-830
- 11-digit product format
- 103700830
- Labeler code
- 10370
- Product ID
- 10370-830_0c13ca26-597e-4886-b085-85bc95eb3ceb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- CAPSULE, COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA074984
- Marketing category
- ANDA
- Marketing start
- 2015-10-01
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 180 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [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 product | product | 10370-830 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 10370-830 | 10370-830-05 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 10370-830 | 10370-830-09 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 10370-830 | 10370-830-11 | I | Inactivated by FDA | 2026-08-03 |
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.
| Dataset | Scope | Package NDC |
|---|---|---|
| excluded product | product | |
| excluded package | package | 10370-830-11 |
| excluded package | package | 10370-830-05 |
| excluded package | package | 10370-830-09 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074984-001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | |
| A074984-002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | |
| A074984-003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | |
| A074984-004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074984-001 | AB3 |
| A074984-002 | AB3 |
| A074984-003 | AB3 |
| A074984-004 | AB3 |
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 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A074984-001 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-002 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-003 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-004 | AB3 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-001 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-002 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-003 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-004 | AB3 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-003 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-004 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-002 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-003 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-004 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-003 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-004 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-002 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-003 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-004 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-003 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-004 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-003 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-004 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074984-001 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074984-002 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074984-003 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074984-004 | AB3 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074984-001 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074984-002 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074984-003 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074984-004 | AB3 | 1 | d06236e962d9… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 61ebbccf-eedf-453b-940e-dba67b7a5fef | Product name | 4 | 20260107 |
| a8d6eaa3-afcc-47e5-be12-0c9251fc8740 | Product name | 1 | 20251124 |
| f6700316-a6ba-5e59-3413-8ede05ae58b9 | Product name | 7 | 20250625 |
| 8615f7a1-1e8f-8281-8601-d7a637926d1f | Product name | 4 | 20250522 |
| 3a9daa2f-bcd1-13de-a1b4-6172caa7f308 | Product name | 2 | 20240419 |
| f7129636-cba8-86c2-8bfb-9e2e2a9c7628 | Product name | 2 | 20240314 |
| 378290be-e30f-0e68-1201-165e93c337e8 | Product name | 3 | 20231212 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| c733b56e-b0b5-4495-9857-0256a8242279 | Product name | 1 | 20220520 |
| f4df4721-60d9-7fd2-a665-5c3c9f55af81 | Product name | 2 | 20171003 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 10370-830-05 | 2022-09-23 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
| 10370-830-09 | 2022-09-23 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
| 10370-830-11 | 2022-09-23 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
| 10370-830-05 | 2022-07-29 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
| 10370-830-09 | 2022-07-29 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
| 10370-830-11 | 2022-07-29 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10370-830-05 | Diltiazem HydrochlorideExtended-Release | 500 in 1 BOTTLE | CAPSULE, COATED, EXTENDED RELEAS | 500 | 10 | |
| 10370-830-09 | Diltiazem HydrochlorideExtended-Release | 90 in 1 BOTTLE | CAPSULE, COATED, EXTENDED RELEAS | 90 | 10 | |
| 10370-830-11 | Diltiazem HydrochlorideExtended-Release | 30 in 1 BOTTLE | CAPSULE, COATED, EXTENDED RELEAS | 30 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10370-830-05 | EA - Each | 10370-830 | fac92bb3-b0ba-4acb-b28f-4a28a6220652 | 1 | 2017-03-06 |
| 10370-830-09 | EA - Each | 10370-830 | 0d89dcc2-b422-4b4c-9fcb-98004ff95282 | 1 | 2017-03-06 |
| 10370-830-11 | EA - Each | 10370-830 | 8cf33e22-32e7-4e8a-8b6c-f4171db62b73 | 1 | 2016-10-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10370-830 | DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [ENDO USA, INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20241212_a66ad880-cdab-435a-a6f2-574cfdfd1ac3.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 |
|---|---|---|---|---|---|---|
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | fb6a6199-bb70-476e-a2a2-b7594c9c001a | 2026-07-10 | Warnings, Adverse reactions | 074984 ANDA074984 |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | American Health Packaging | 11b43a17-8038-462b-8902-259431ad5256 | 2026-06-22 | Warnings, Adverse reactions | 074984 ANDA074984 |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | fe7ca564-16b8-4c54-aa09-3e2ed0c2596a | 2024-05-17 | Warnings, Adverse reactions | 074984 ANDA074984 |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | de2a0c48-7fc4-4760-b465-a79299876e6e | 2024-04-05 | Warnings, Adverse reactions | 074984 ANDA074984 |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 74232d69-1a8c-449d-8e8e-85488e6cc8f8 | 2024-04-03 | Warnings, Adverse reactions | 074984 ANDA074984 |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 0e9b4421-bc43-4a77-b49b-e3f53d1e0f01 | 2024-01-10 | Warnings, Adverse reactions | 074984 ANDA074984 |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | a6cc3b99-2c0f-4d8a-8393-ec042ed7c892 | 2024-01-10 | Warnings, Adverse reactions | 074984 ANDA074984 |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a6 | 2024-01-10 | Warnings, Adverse reactions | 074984 ANDA074984 |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 762c3007-b22f-4d35-87b4-191fec8b3a9a | 2023-11-20 | Warnings, Adverse reactions | 074984 ANDA074984 |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | eed8cfeb-6ec7-4914-b8e0-a5c3d623c9a4 | 2023-11-20 | Warnings, Adverse reactions | 074984 ANDA074984 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 830845 | dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule | PSN | eed8cfeb-6ec7-4914-b8e0-a5c3d623c9a4 | 101 |
| 830845 | dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule | PSN | fe7ca564-16b8-4c54-aa09-3e2ed0c2596a | 101 |
| 830845 | 24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule | SCD | eed8cfeb-6ec7-4914-b8e0-a5c3d623c9a4 | 101 |
| 830845 | 24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule | SCD | fe7ca564-16b8-4c54-aa09-3e2ed0c2596a | 101 |
| 830845 | diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule | SY | eed8cfeb-6ec7-4914-b8e0-a5c3d623c9a4 | 101 |
| 830845 | diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule | SY | fe7ca564-16b8-4c54-aa09-3e2ed0c2596a | 101 |
| 830861 | dilTIAZem HCl 120 MG 24HR Extended Release Oral Capsule | PSN | fe88ae79-095c-46db-966f-45cbcfaf6f01 | 34 |
| 830845 | dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule | PSN | fe88ae79-095c-46db-966f-45cbcfaf6f01 | 34 |
| 830837 | dilTIAZem HCl 240 MG 24HR Extended Release Oral Capsule | PSN | fe88ae79-095c-46db-966f-45cbcfaf6f01 | 34 |
| 830801 | dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral Capsule | PSN | fe88ae79-095c-46db-966f-45cbcfaf6f01 | 34 |
| 830861 | 24 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule | SCD | fe88ae79-095c-46db-966f-45cbcfaf6f01 | 34 |
| 830845 | 24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule | SCD | fe88ae79-095c-46db-966f-45cbcfaf6f01 | 34 |
| 830837 | 24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule | SCD | fe88ae79-095c-46db-966f-45cbcfaf6f01 | 34 |
| 830801 | 24 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule | SCD | fe88ae79-095c-46db-966f-45cbcfaf6f01 | 34 |
| 830861 | diltiazem HCl 120 MG 24 HR Extended Release Oral Capsule | SY | fe88ae79-095c-46db-966f-45cbcfaf6f01 | 34 |
| 830845 | diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule | SY | fe88ae79-095c-46db-966f-45cbcfaf6f01 | 34 |
| 830837 | diltiazem HCl 240 MG 24 HR Extended Release Oral Capsule | SY | fe88ae79-095c-46db-966f-45cbcfaf6f01 | 34 |
| 830801 | diltiazem hydrochloride 300 MG 24 HR Extended Release Oral Capsule | SY | fe88ae79-095c-46db-966f-45cbcfaf6f01 | 34 |
| 830861 | dilTIAZem HCl 120 MG 24HR Extended Release Oral Capsule | PSN | a66ad880-cdab-435a-a6f2-574cfdfd1ac3 | 10 |
| 830845 | dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule | PSN | a66ad880-cdab-435a-a6f2-574cfdfd1ac3 | 10 |
| 830837 | dilTIAZem HCl 240 MG 24HR Extended Release Oral Capsule | PSN | a66ad880-cdab-435a-a6f2-574cfdfd1ac3 | 10 |
| 830801 | dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral Capsule | PSN | a66ad880-cdab-435a-a6f2-574cfdfd1ac3 | 10 |
| 830861 | 24 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule | SCD | a66ad880-cdab-435a-a6f2-574cfdfd1ac3 | 10 |
| 830845 | 24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule | SCD | a66ad880-cdab-435a-a6f2-574cfdfd1ac3 | 10 |
| 830837 | 24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule | SCD | a66ad880-cdab-435a-a6f2-574cfdfd1ac3 | 10 |
| 830801 | 24 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule | SCD | a66ad880-cdab-435a-a6f2-574cfdfd1ac3 | 10 |
| 830861 | diltiazem HCl 120 MG 24 HR Extended Release Oral Capsule | SY | a66ad880-cdab-435a-a6f2-574cfdfd1ac3 | 10 |
| 830845 | diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule | SY | a66ad880-cdab-435a-a6f2-574cfdfd1ac3 | 10 |
| 830837 | diltiazem HCl 240 MG 24 HR Extended Release Oral Capsule | SY | a66ad880-cdab-435a-a6f2-574cfdfd1ac3 | 10 |
| 830801 | diltiazem hydrochloride 300 MG 24 HR Extended Release Oral Capsule | SY | a66ad880-cdab-435a-a6f2-574cfdfd1ac3 | 10 |
| 830861 | dilTIAZem HCl 120 MG 24HR Extended Release Oral Capsule | PSN | 11b43a17-8038-462b-8902-259431ad5256 | 9 |
| 830861 | dilTIAZem HCl 120 MG 24HR Extended Release Oral Capsule | PSN | 2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec | 9 |
| 830845 | dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule | PSN | 2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec | 9 |
| 830845 | dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule | PSN | 11b43a17-8038-462b-8902-259431ad5256 | 9 |
| 830837 | dilTIAZem HCl 240 MG 24HR Extended Release Oral Capsule | PSN | 11b43a17-8038-462b-8902-259431ad5256 | 9 |
| 830837 | dilTIAZem HCl 240 MG 24HR Extended Release Oral Capsule | PSN | 2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec | 9 |
| 830801 | dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral Capsule | PSN | 11b43a17-8038-462b-8902-259431ad5256 | 9 |
| 830861 | 24 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule | SCD | 11b43a17-8038-462b-8902-259431ad5256 | 9 |
| 830861 | 24 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule | SCD | 2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec | 9 |
| 830845 | 24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule | SCD | 11b43a17-8038-462b-8902-259431ad5256 | 9 |
| 830845 | 24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule | SCD | 2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec | 9 |
| 830837 | 24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule | SCD | 11b43a17-8038-462b-8902-259431ad5256 | 9 |
| 830837 | 24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule | SCD | 2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec | 9 |
| 830801 | 24 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule | SCD | 11b43a17-8038-462b-8902-259431ad5256 | 9 |
| 830861 | diltiazem HCl 120 MG 24 HR Extended Release Oral Capsule | SY | 2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec | 9 |
| 830861 | diltiazem HCl 120 MG 24 HR Extended Release Oral Capsule | SY | 11b43a17-8038-462b-8902-259431ad5256 | 9 |
| 830845 | diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule | SY | 11b43a17-8038-462b-8902-259431ad5256 | 9 |
| 830845 | diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule | SY | 2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec | 9 |
| 830837 | diltiazem HCl 240 MG 24 HR Extended Release Oral Capsule | SY | 11b43a17-8038-462b-8902-259431ad5256 | 9 |
| 830837 | diltiazem HCl 240 MG 24 HR Extended Release Oral Capsule | SY | 2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec | 9 |
| 830801 | diltiazem hydrochloride 300 MG 24 HR Extended Release Oral Capsule | SY | 11b43a17-8038-462b-8902-259431ad5256 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10370-830-05 | 10370083005 | 500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-830-05) | 2016-12-12 | 0000-00-00 | No | No | Current |
| 10370-830-09 | 10370083009 | 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-830-09) | 2017-01-12 | 0000-00-00 | No | No | Current |
| 10370-830-11 | 10370083011 | 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-830-11) | 2016-09-07 | 0000-00-00 | No | No | Current |