Ergocalciferol Capsules,

Product NDC: 53401-021
11-digit product format: 534010021
Labeler code: 53401
Product ID: 53401-021_564537cc-0d46-3656-e063-6294a90ace99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ergocalciferol Capsules,
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA204276
Marketing category: ANDA
Marketing start: 2018-12-10
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204276-001	ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2018-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A204276-001	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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204276-001	ERGOCALCIFEROL	50000IU	CAPSULE / ORAL	AA	2018-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204276-001	ERGOCALCIFEROL	50000IU	CAPSULE / ORAL	AA	2018-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204276-001	ERGOCALCIFEROL	50000IU	CAPSULE / ORAL	AA	2018-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204276-001	ERGOCALCIFEROL	50000IU	CAPSULE / ORAL	AA	2018-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204276-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204276-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204276-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204276-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204276-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204276-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204276-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204276-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204276-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204276-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204276-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204276-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204276-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204276-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204276-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204276-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204276-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204276-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204276-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204276-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204276-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204276-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204276-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204276-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204276-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204276-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204276-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204276-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204276-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204276-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204276-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204276-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204276-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204276-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204276-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204276-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204276-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204276-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204276-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204276-001	AA	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Ergocalciferol Capsules,
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ERGOCALCIFEROL	1.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VS041H42XC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1367410	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
56454180-0ae8-a267-e063-6394a90a491c	Available on FDA.report

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.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	REMEDYREPACK INC.	75fa8580-3322-473d-b836-4929f8c40165	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	Aphena Pharma Solutions - Tennessee, LLC	56454180-0ae8-a267-e063-6394a90a491c	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276 ndc (product): 53401-021
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	Proficient Rx LP	c22a625f-f526-477a-85e5-23abe5771284	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol	ERGOCALCIFEROL CAPSULES,	A-S Medication Solutions	d9d45422-b7a2-4f8a-a00d-2754f8b26dd1	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	Northwind Health Company, LLC	db98e670-02ef-208a-e053-2995a90aca92	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	Preferred Pharmaceuticals Inc.	eefdca6e-e5b7-4323-aa92-e0bb8275947d	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	Bryant Ranch Prepack	af8a25f4-7a4d-47ed-827f-308f687d9eae	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol	ERGOCALCIFEROL CAPSULES,	Bryant Ranch Prepack	2cdd7f42-bc90-4b41-9936-acc7d9b79088	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	Epic Pharma LLC	e58cfb46-f8a7-4327-bbe8-da4d4be2bd1d	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol (Vitamin D2)	ERGOCALCIFEROL (VITAMIN D2)	Advanced Rx Pharmacy of Tennessee, LLC	bc3ed1e0-0bb9-1cc0-e053-2995a90a48fe	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol	ERGOCALCIFEROL CAPSULES,	Bryant Ranch Prepack	5dc330a2-a12d-4fd3-8d91-a8d9f31b2eae	2024-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol	ERGOCALCIFEROL	NuCare Pharmaceuticals,Inc.	b43d7134-6c68-556b-e053-2995a90a38ef	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VS041H42XC	ERGOCALCIFEROL	50-14-6	ERGOCALCIFEROL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53401-021-08	53401002108	8 CAPSULE in 1 BOTTLE (53401-021-08)	8 capsule	2026-07-08	No	No	Current
53401-021-12	53401002112	12 CAPSULE in 1 BOTTLE (53401-021-12)	12 capsule	2026-07-08	No	No	Current
53401-021-13	53401002113	13 CAPSULE in 1 BOTTLE (53401-021-13)	13 capsule	2026-07-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units	Aphena Pharma Solutions - Tennessee, LLC	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	1