ERGOCALCIFEROL

Product NDC: 62332-464
Requested package NDC: 62332-464-31
11-digit product format: 623320464
Labeler code: 62332
Product ID: 62332-464_9edbbfdd-5eee-49be-abf8-38b9dcb946a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ERGOCALCIFEROL
Dosage form: CAPSULE
Route: ORAL
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA040833
Marketing category: ANDA
Marketing start: 2018-04-30
Marketing end: 0000-00-00
Substance: ERGOCALCIFEROL
Active strength: 1 mg/1
Pharmacologic classes: Ergocalciferols [CS],Provitamin D2 Compound [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	62332-464	62332-464-31	I	Inactivated by FDA		2026-08-03

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
A040833-001	ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2009-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040833-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`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	A040833-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040833-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040833-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040833-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040833-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040833-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040833-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040833-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040833-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040833-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040833-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040833-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040833-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040833-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040833-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040833-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040833-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040833-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040833-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040833-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040833-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040833-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040833-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040833-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040833-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040833-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040833-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040833-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040833-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040833-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040833-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040833-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040833-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040833-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040833-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040833-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040833-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040833-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040833-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040833-001	AA	1	`cb3db0bc1861…`

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
62332-464-31	ERGOCALCIFEROL	100 in 1 BOTTLE	CAPSULE	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62332-464-31	EA - Each	62332-464	0687f5e6-1ae7-4d74-99a5-6daa4c1fc45b	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62332-464	ERGOCALCIFEROL CAPSULE [ALEMBIC PHARMACEUTICALS INC.]	5	Legacy NDC, 1 package rows	20230124_87e80b1f-e376-45ba-825b-a6fda4b82325.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ergocalciferol	ERGOCALCIFEROL	Chartwell RX, LLC	6490770b-82ef-4e7c-be93-999174d4ee59	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040833 application number: ANDA040833

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	87e80b1f-e376-45ba-825b-a6fda4b82325	5
1367410	ergocalciferol 1.25 MG Oral Capsule	SCD	87e80b1f-e376-45ba-825b-a6fda4b82325	5
1367410	vit-D 1.25 MG Oral Capsule	SY	87e80b1f-e376-45ba-825b-a6fda4b82325	5
1367410	vitamin D 1.25 MG Oral Capsule	SY	87e80b1f-e376-45ba-825b-a6fda4b82325	5
1367410	vitamin D2 1250 MCG Oral Capsule	SY	87e80b1f-e376-45ba-825b-a6fda4b82325	5
1367410	vitamin D2 50,000 UNT Oral Capsule	SY	87e80b1f-e376-45ba-825b-a6fda4b82325	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62332-464-31	62332046431	100 CAPSULE in 1 BOTTLE (62332-464-31)	100 capsule	2018-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ergocalciferol Capsules. Vitamin D (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units ) Rx Only	Golden State Medical Supply, Inc.	2023-08-15	HUMAN PRESCRIPTION DRUG LABEL	7
Vitamin D (Ergocalciferol Capsules, USP) 8450001/0822 Rx only	American Health Packaging	2023-02-27	HUMAN PRESCRIPTION DRUG LABEL	4
Vitamin D (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units ) Rx Only	Alembic Pharmaceuticals Inc. \| Swiss Caps AG	2023-01-24	Human Prescription Drug Label	5