Ergocalciferol
- Product NDC
- 69452-151
- 11-digit product format
- 694520151
- Labeler code
- 69452
- Product ID
- 69452-151_44ea5b7f-37c7-ed1d-e063-6294a90ab33f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ergocalciferol
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA080704
- Marketing category
- ANDA
- Marketing start
- 2016-06-15
- Substance
- ERGOCALCIFEROL
- Active strength
- 1.25 mg/1
- Pharmacologic classes
- Ergocalciferols [CS], Provitamin D2 Compound [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 |
|---|---|---|---|---|---|---|---|
| A080704-001 | VITAMIN D | ERGOCALCIFEROL | 50,000 IU | CAPSULE / ORAL | AA | Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A080704-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A080704-001 | VITAMIN D | 50,000 IU | CAPSULE / ORAL | AA | Approved before 1982 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A080704-001 | AA | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ergocalciferol | ERGOCALCIFEROL | REMEDYREPACK INC. | a80436e0-b507-4e7b-9a60-a9d5ddc4a045 | 2026-06-24 | Warnings, Adverse reactions | 080704 ANDA080704 |
| Ergocalciferol | ERGOCALCIFEROL | Bryant Ranch Prepack | 0d230fd8-2ea7-4dd6-a506-5f7804e539fc | 2026-05-20 | Warnings, Adverse reactions | 080704 ANDA080704 |
| Ergocalciferol | ERGOCALCIFEROL | Bryant Ranch Prepack | c4793165-6647-4dba-b100-3986739cd01e | 2026-05-19 | Warnings, Adverse reactions | 080704 ANDA080704 |
| Ergocalciferol | ERGOCALCIFEROL | Bryant Ranch Prepack | 39b72d09-cedc-4130-89a3-1ea03f58ba04 | 2026-05-14 | Warnings, Adverse reactions | 080704 ANDA080704 |
| Ergocalciferol | ERGOCALCIFEROL | St. Mary's Medical Park Pharmacy | 5f4ef344-7880-3375-e053-2a91aa0a47b8 | 2026-05-05 | Warnings, Adverse reactions | 080704 ANDA080704 |
| Ergocalciferol | ERGOCALCIFEROL | PD-Rx Pharmaceuticals, Inc. | 2475e731-0072-4787-8a40-09137883c625 | 2026-05-05 | Warnings, Adverse reactions | 080704 ANDA080704 |
| Ergocalciferol | ERGOCALCIFEROL | NuCare Pharmaceuticals, Inc. | 492452d6-2b32-39c0-e054-00144ff8d46c | 2026-04-30 | Warnings, Adverse reactions | 080704 ANDA080704 |
| Ergocalciferol | ERGOCALCIFEROL | Preferred Pharmaceuticals Inc. | 1cd4afc6-ef90-4e7b-9f11-2bfbd137524c | 2026-03-17 | Warnings, Adverse reactions | 080704 ANDA080704 |
| Ergocalciferol | ERGOCALCIFEROL | AvKARE | f55eafcd-dfd9-fdae-c39f-ae07aa852ce1 | 2025-12-03 | Warnings, Adverse reactions | 080704 ANDA080704 |
| Ergocalciferol | ERGOCALCIFEROL | Bionpharma Inc. | 2a8d73d6-9991-401b-ab8b-81f22e5a0695 | 2025-12-01 | Warnings, Adverse reactions | 080704 ANDA080704 69452-151 |
| Vitamin D | VITAMIN D | DirectRX | 84647b52-3c4c-31bb-e053-2991aa0a8a7e | 2025-03-19 | Warnings, Adverse reactions | 080704 ANDA080704 |
| Ergocalciferol | ERGOCALCIFEROL | Aphena Pharma Solutions - Tennessee, LLC | c538ac91-2507-4f42-8f7a-013510539b30 | 2024-05-13 | Warnings, Adverse reactions | 080704 ANDA080704 |
| Ergocalciferol | ERGOCALCIFEROL | Bryant Ranch Prepack | 9e63d720-cce8-4a59-b311-26cfca113957 | 2024-04-05 | Warnings, Adverse reactions | 080704 ANDA080704 |
| Ergocalciferol | ERGOCALCIFEROL | Aphena Pharma Solutions - Tennessee, LLC | 2841b0ba-3b09-4f03-a060-9fb7f1af8344 | 2018-12-18 | Warnings, Adverse reactions | 080704 ANDA080704 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ergocalciferol
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 2a8d73d6-9991-401b-ab8b-81f22e5a0695 | 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 |
|---|---|---|---|---|---|---|
| 69452-151-20 | Ergocalciferol | 100 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 100 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69452-151-20 | EA - Each | 69452-151 | 0126c1f8-038e-4f90-a635-5bed4ed4696b | 1 | 2016-07-19 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Ergocalciferol | ACTIVE INGREDIENT | VS041H42XC | ERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.] | 2 | |
| Ergocalciferol | ACTIVE MOIETY | VS041H42XC | ERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.] | 2 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | ERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69452-151-20 | 69452015120 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-151-20) | 2016-06-15 | 0000-00-00 | No | No | Current |