diltiazem hydrochloride
- Product NDC
- 71335-1897
- 11-digit product format
- 713351897
- Labeler code
- 71335
- Product ID
- 71335-1897_90a6eaea-ad5f-4d7a-8159-6c8f4b2562dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diltiazem hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA208783
- Marketing category
- ANDA
- Marketing start
- 2019-06-14
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 360 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208783-001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | |
| A208783-002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | |
| A208783-003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | |
| A208783-004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | |
| A208783-005 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208783-001 | AB3 |
| A208783-002 | AB3 |
| A208783-003 | AB3 |
| A208783-004 | AB3 |
| A208783-005 | 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 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208783-001 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-002 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-003 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-004 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-005 | AB3 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-001 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-002 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-003 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-004 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-005 | AB3 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-003 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-004 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-005 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-002 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-003 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-004 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-005 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-003 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-004 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-005 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-002 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-003 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-004 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-005 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-003 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-004 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-005 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-003 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-004 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-005 | AB3 | 1 | 5bbf6a4d5a75… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- diltiazem hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DILTIAZEM HYDROCHLORIDE | 360 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| OLH94387TE | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 830795 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0089fc7a-a7aa-4873-b699-39a1b21616ca | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-1897-1 | diltiazem hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 103 | |
| 71335-1897-2 | diltiazem hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | 103 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-1897 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 2 package rows | 20231111_0089fc7a-a7aa-4873-b699-39a1b21616ca.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 | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | ec928ee5-0809-4ba5-82ca-ecfed99ebb5a | 2026-07-21 | Warnings, Adverse reactions | 208783 ANDA208783 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | REMEDYREPACK INC. | 5e935265-d0fc-4223-835f-72426eeea6c4 | 2026-04-10 | Warnings, Adverse reactions | 208783 ANDA208783 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 3d594530-885f-45c7-b8a5-fd7e503ff83f | 2026-04-06 | Warnings, Adverse reactions | 208783 ANDA208783 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | a469b24a-fbec-4a2d-8b4c-b62c2b2c66f6 | 2026-02-17 | Warnings, Adverse reactions | 208783 ANDA208783 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | e6d9397c-f8a2-42d6-88ca-55060b1d073a | 2025-08-26 | Warnings, Adverse reactions | 208783 ANDA208783 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 9041cc05-29d2-41ca-a368-e953bf3443b5 | 2025-08-25 | Warnings, Adverse reactions | 208783 ANDA208783 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 0089fc7a-a7aa-4873-b699-39a1b21616ca | 2025-08-20 | Warnings, Adverse reactions | 208783 ANDA208783 71335-1897 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Ingenus Pharmaceuticals, LLC | 355f560a-8ebb-4661-ad74-2a22f707d7f8 | 2025-06-17 | Warnings, Adverse reactions | 208783 ANDA208783 |
| Diltiazem HCL ER | DILTIAZEM HCL ER | Direct_Rx | f1ea85b2-ecd2-5867-e053-2a95a90a24dc | 2025-01-22 | Warnings, Adverse reactions | 208783 ANDA208783 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 70f167a1-ec7f-4969-b446-166af3e52c05 | 2024-09-13 | Warnings, Adverse reactions | 208783 ANDA208783 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 830795 | dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral Capsule | PSN | 0089fc7a-a7aa-4873-b699-39a1b21616ca | 103 |
| 830795 | 24 HR diltiazem hydrochloride 360 MG Extended Release Oral Capsule | SCD | 0089fc7a-a7aa-4873-b699-39a1b21616ca | 103 |
| 830795 | diltiazem hydrochloride 360 MG 24 HR Extended Release Oral Capsule | SY | 0089fc7a-a7aa-4873-b699-39a1b21616ca | 103 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71335-1897-1 | 71335189701 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1897-1) | 2021-06-29 | 0000-00-00 | No | No | Current |
| 71335-1897-2 | 71335189702 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1897-2) | 2021-06-29 | 0000-00-00 | No | No | Current |