VITAMIN D
- Product NDC
- 51655-774
- Requested package NDC
- 51655-774-27
- 11-digit product format
- 516550774
- Labeler code
- 51655
- Product ID
- 51655-774_49739ebf-fa64-df44-e063-6294a90a2ea2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ergocalciferol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA090455
- Marketing category
- ANDA
- Marketing start
- 2022-08-29
- Substance
- ERGOCALCIFEROL
- Active strength
- 1.25 mg/1
- Pharmacologic classes
- Ergocalciferols [CS], Provitamin D2 Compound [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090455-001 | ERGOCALCIFEROL | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090455-001 | AA |
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 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | RS | 2010-08-03 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090455-001 | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | 2010-08-03 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090455-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090455-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090455-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090455-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090455-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090455-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090455-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090455-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090455-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090455-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090455-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090455-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090455-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090455-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090455-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090455-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090455-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090455-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090455-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090455-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090455-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090455-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090455-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090455-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090455-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090455-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090455-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090455-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090455-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090455-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090455-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090455-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090455-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090455-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090455-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090455-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090455-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090455-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A090455-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090455-001 | AA | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VITAMIN D
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ERGOCALCIFEROL | 1.25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VS041H42XC | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1367410 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f3402462-5d86-b4c9-e053-2a95a90aaab0 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| a1367f07-14a3-4895-a6e7-61ee9285308b | Product name | 1 | 20190415 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51655-774-27 | VITAMIN D | 12 in 1 BOTTLE, PLASTIC | CAPSULE | 12 | 4 | |
| 51655-774-52 | VITAMIN D | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 4 | |
| 51655-774-80 | VITAMIN D | 8 in 1 BOTTLE, PLASTIC | CAPSULE | 8 | 4 |
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 |
|---|---|---|---|---|---|---|
| VITAMIN D | ERGOCALCIFEROL | REMEDYREPACK INC. | 3fe92511-0b4a-43f4-9c89-c8599469c1e2 | 2026-07-14 | Warnings, Adverse reactions | 090455 ANDA090455 |
| VITAMIN D | ERGOCALCIFEROL | Aphena Pharma Solutions - Tennessee, LLC | 3c0f4142-cc1f-43de-8677-ee06b6f4fc10 | 2026-06-17 | Warnings, Adverse reactions | 090455 ANDA090455 |
| VITAMIN D | ERGOCALCIFEROL | AvPAK | a2b82923-f0dd-641f-e053-2995a90a7c4a | 2026-01-08 | Warnings, Adverse reactions | 090455 ANDA090455 |
| VITAMIN D | ERGOCALCIFEROL | Northwind Health Company, LLC | f3402462-5d86-b4c9-e053-2a95a90aaab0 | 2026-01-01 | Warnings, Adverse reactions | 090455 ANDA090455 51655-774-27 51655-774 51655077427 |
| VITAMIN D | ERGOCALCIFEROL | Preferred Pharmaceuticals, Inc. | ba2076ef-1650-45e1-b092-a4c449dd6210 | 2025-10-07 | Warnings, Adverse reactions | 090455 ANDA090455 |
| VITAMIN D | ERGOCALCIFEROL | Golden State Medical Supply, Inc. | 26aba724-8990-def9-e063-6394a90a991d | 2025-04-15 | Warnings, Adverse reactions | 090455 ANDA090455 |
| VITAMIN D | ERGOCALCIFEROL | PD-Rx Pharmaceuticals, Inc. | 7e9b75e3-eb7c-4227-b953-166ac6897e54 | 2025-04-01 | Warnings, Adverse reactions | 090455 ANDA090455 |
| VITAMIN D | ERGOCALCIFEROL | Strides Pharma Science Limited | 2c4c0a36-12cf-444d-9d57-de983eef4d36 | 2025-03-10 | Warnings, Adverse reactions | 090455 ANDA090455 |
| VITAMIN D | ERGOCALCIFEROL | Bryant Ranch Prepack | a8aa37f4-7e94-4425-beea-49c938294a23 | 2024-10-02 | Warnings, Adverse reactions | 090455 ANDA090455 |
| VITAMIN D | ERGOCALCIFEROL | Proficient Rx LP | 548365c1-b51c-4a8b-ae3d-50b41aba12db | 2022-04-01 | Warnings, Adverse reactions | 090455 ANDA090455 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1367410 | ergocalciferol 1.25 MG (50,000 UNT) Oral Capsule | PSN | f3402462-5d86-b4c9-e053-2a95a90aaab0 | 4 |
| 1367410 | ergocalciferol 1.25 MG Oral Capsule | SCD | f3402462-5d86-b4c9-e053-2a95a90aaab0 | 4 |
| 1367410 | vit-D 1.25 MG Oral Capsule | SY | f3402462-5d86-b4c9-e053-2a95a90aaab0 | 4 |
| 1367410 | vitamin D 1.25 MG Oral Capsule | SY | f3402462-5d86-b4c9-e053-2a95a90aaab0 | 4 |
| 1367410 | vitamin D2 1250 MCG Oral Capsule | SY | f3402462-5d86-b4c9-e053-2a95a90aaab0 | 4 |
| 1367410 | vitamin D2 50,000 UNT Oral Capsule | SY | f3402462-5d86-b4c9-e053-2a95a90aaab0 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51655-774-27 | 51655077427 | 12 CAPSULE in 1 BOTTLE, PLASTIC (51655-774-27) | 12 capsule | 2022-09-21 | No | No | Current |