Calcitriol
- Product NDC
- 64380-724
- Requested package NDC
- 64380-724-06
- 11-digit product format
- 643800724
- Labeler code
- 64380
- Product ID
- 64380-724_0c6ffbc5-f012-42c6-9847-c49e1708259b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcitriol Capsules 0.5 mcg
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA091356
- Marketing category
- ANDA
- Marketing start
- 2016-12-27
- Substance
- CALCITRIOL
- Active strength
- .5 ug/1
- Pharmacologic classes
- Cholecalciferol [CS], Vitamin D3 Analog [EPC]
- 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 |
|---|---|---|---|---|---|---|---|
| A091356-001 | CALCITRIOL | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | |
| A091356-002 | CALCITRIOL | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091356-001 | AB |
| A091356-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RS | 2014-12-12 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | 2014-12-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | 2014-12-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | 2014-12-12 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | 2014-12-12 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | 2014-12-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091356-001 | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | 2014-12-12 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091356-002 | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | 2014-12-12 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091356-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091356-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091356-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091356-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091356-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091356-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091356-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091356-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091356-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091356-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091356-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091356-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091356-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091356-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091356-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091356-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091356-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091356-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091356-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091356-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091356-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091356-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091356-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091356-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091356-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091356-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091356-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091356-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091356-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091356-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091356-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091356-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091356-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091356-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091356-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091356-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091356-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091356-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091356-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091356-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Calcitriol
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CALCITRIOL | .5 ug/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| FXC9231JVH | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bebefb2a-7365-48e2-9681-83ed4b41e26e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 09b728d3-9521-67a6-95fe-30969d1d5187 | Product name | 5 | 20240828 |
| 5f07db61-095c-acca-e8e9-d0916b4c1947 | Product name | 2 | 20200616 |
| 98f556da-44be-c658-496e-47884da4e67b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64380-724-06 | Calcitriol | 100 in 1 CONTAINER | CAPSULE | 100 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64380-724-06 | EA - Each | 64380-724 | 8ca954e8-6989-4776-b80c-6cc6bb78f77c | 1 | 2015-02-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64380-724 | CALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES PHARMA SCIENCE LIMITED] | 11 | Current NDC, Legacy NDC, 1 package rows | 20250311_bebefb2a-7365-48e2-9681-83ed4b41e26e.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 |
|---|---|---|---|---|---|---|
| Calcitriol | CALCITRIOL CAPSULES 0.25 MCG | Strides Pharma Science Limited | bebefb2a-7365-48e2-9681-83ed4b41e26e | 2026-06-23 | Warnings, Adverse reactions | 091356 ANDA091356 64380-724-06 64380-724 64380072406 |
| Calcitriol | CALCITRIOL CAPSULES 0.25 MCG | Cardinal Health 107, LLC | 32205cfc-7939-4105-a4b9-2ed327c5e0cc | 2026-04-15 | Warnings, Adverse reactions | 091356 ANDA091356 |
| Calcitriol | CALCITRIOL | Chartwell RX, LLC | 36820cd0-7b30-4454-9005-09d71e1d5796 | 2025-12-09 | Warnings, Adverse reactions | 091356 ANDA091356 |
| Calcitriol | CALCITRIOL CAPSULES 0.25 MCG | American Health Packaging | 261398eb-80b8-4c3d-9d2b-3a8004347a75 | 2025-11-13 | Warnings, Adverse reactions | 091356 ANDA091356 |
| CALCITRIOL | CALCITRIOL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 2b48f57a-c023-485d-b846-cab3aaaad486 | 2025-03-10 | Warnings, Adverse reactions | 091356 ANDA091356 |
| Calcitriol | CALCITRIOL CAPSULES 0.25 MCG | Aphena Pharma Solutions - Tennessee, LLC | 29b8cc1f-0491-0a95-e063-6294a90a223d | 2024-12-20 | Warnings, Adverse reactions | 091356 ANDA091356 |
| CALCITRIOL | CALCITRIOL | A-S Medication Solutions | 26ac6b4d-9576-4710-856b-aca114ea84cf | 2024-12-12 | Warnings, Adverse reactions | 091356 ANDA091356 |
| Calcitriol | CALCITRIOL CAPSULES 0.25 MCG | Bryant Ranch Prepack | 3637da5e-55cf-40ed-9bea-18c27b595627 | 2024-07-10 | Warnings, Adverse reactions | 091356 ANDA091356 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308867 | calcitriol 0.25 MCG Oral Capsule | PSN | bebefb2a-7365-48e2-9681-83ed4b41e26e | 11 |
| 308868 | calcitriol 0.5 MCG Oral Capsule | PSN | bebefb2a-7365-48e2-9681-83ed4b41e26e | 11 |
| 308867 | calcitriol 0.00025 MG Oral Capsule | SCD | bebefb2a-7365-48e2-9681-83ed4b41e26e | 11 |
| 308868 | calcitriol 0.0005 MG Oral Capsule | SCD | bebefb2a-7365-48e2-9681-83ed4b41e26e | 11 |
| 308867 | calcitriol 0.25 MCG Oral Capsule | SY | bebefb2a-7365-48e2-9681-83ed4b41e26e | 11 |
| 308868 | calcitriol 0.5 MCG Oral Capsule | SY | bebefb2a-7365-48e2-9681-83ed4b41e26e | 11 |
| 308867 | calcitriol 0.25 MCG Oral Capsule | PSN | 3637da5e-55cf-40ed-9bea-18c27b595627 | 9 |
| 308868 | calcitriol 0.5 MCG Oral Capsule | PSN | 3637da5e-55cf-40ed-9bea-18c27b595627 | 9 |
| 308867 | calcitriol 0.00025 MG Oral Capsule | SCD | 3637da5e-55cf-40ed-9bea-18c27b595627 | 9 |
| 308868 | calcitriol 0.0005 MG Oral Capsule | SCD | 3637da5e-55cf-40ed-9bea-18c27b595627 | 9 |
| 308867 | calcitriol 0.25 MCG Oral Capsule | SY | 3637da5e-55cf-40ed-9bea-18c27b595627 | 9 |
| 308868 | calcitriol 0.5 MCG Oral Capsule | SY | 3637da5e-55cf-40ed-9bea-18c27b595627 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64380-724-06 | 64380072406 | 100 CAPSULE in 1 CONTAINER (64380-724-06) | 100 capsule | 2016-12-27 | 0000-00-00 | No | No | Current |