Ergocalciferol

Product NDC: 43063-711
11-digit product format: 430630711
Labeler code: 43063
Product ID: 43063-711_5118a9ac-3c52-0aae-e063-6294a90ada17
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ergocalciferol
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A080704-001	VITAMIN D	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080704-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080704-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080704-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080704-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080704-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080704-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080704-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080704-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080704-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080704-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080704-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080704-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080704-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080704-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080704-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080704-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080704-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080704-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080704-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080704-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080704-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080704-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080704-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080704-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080704-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080704-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080704-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080704-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080704-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080704-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080704-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080704-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080704-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080704-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080704-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080704-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080704-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080704-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080704-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080704-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ergocalciferol
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
2475e731-0072-4787-8a40-09137883c625	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43063-711-12	Ergocalciferol	12 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	12		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-711-12	EA - Each	43063-711	f50618ab-ae07-448c-9e34-c4209080e6c6	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-711	ERGOCALCIFEROL CAPSULE, LIQUID FILLED [PD-RX PHARMACEUTICALS, INC.]	17	Current NDC, Legacy NDC, 1 package rows	20250309_2475e731-0072-4787-8a40-09137883c625.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.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Bryant Ranch Prepack	0d230fd8-2ea7-4dd6-a506-5f7804e539fc	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Bryant Ranch Prepack	c4793165-6647-4dba-b100-3986739cd01e	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Bryant Ranch Prepack	39b72d09-cedc-4130-89a3-1ea03f58ba04	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	St. Mary's Medical Park Pharmacy	5f4ef344-7880-3375-e053-2a91aa0a47b8	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	PD-Rx Pharmaceuticals, Inc.	2475e731-0072-4787-8a40-09137883c625	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704 ndc (product): 43063-711
Ergocalciferol	ERGOCALCIFEROL	NuCare Pharmaceuticals, Inc.	492452d6-2b32-39c0-e054-00144ff8d46c	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Preferred Pharmaceuticals Inc.	1cd4afc6-ef90-4e7b-9f11-2bfbd137524c	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	AvKARE	f55eafcd-dfd9-fdae-c39f-ae07aa852ce1	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Bionpharma Inc.	2a8d73d6-9991-401b-ab8b-81f22e5a0695	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Vitamin D	VITAMIN D	DirectRX	84647b52-3c4c-31bb-e053-2991aa0a8a7e	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Aphena Pharma Solutions - Tennessee, LLC	c538ac91-2507-4f42-8f7a-013510539b30	2024-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Bryant Ranch Prepack	9e63d720-cce8-4a59-b311-26cfca113957	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Aphena Pharma Solutions - Tennessee, LLC	2841b0ba-3b09-4f03-a060-9fb7f1af8344	2018-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1367410	ergocalciferol 1.25 MG (50,000 UNT) Oral Capsule	PSN	2475e731-0072-4787-8a40-09137883c625	19
1367410	ergocalciferol 1.25 MG Oral Capsule	SCD	2475e731-0072-4787-8a40-09137883c625	19
1367410	vit-D 1.25 MG Oral Capsule	SY	2475e731-0072-4787-8a40-09137883c625	19
1367410	vitamin D 1.25 MG Oral Capsule	SY	2475e731-0072-4787-8a40-09137883c625	19
1367410	vitamin D2 1250 MCG Oral Capsule	SY	2475e731-0072-4787-8a40-09137883c625	19
1367410	vitamin D2 50,000 UNT Oral Capsule	SY	2475e731-0072-4787-8a40-09137883c625	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-711-12	43063071112	12 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43063-711-12)	2016-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vitamin D (Ergocalciferol Capsules, USP)	PD-Rx Pharmaceuticals, Inc.	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	19