DRISDOL

Product NDC: 30698-493
Requested package NDC: 30698-493-01
11-digit product format: 306980493
Labeler code: 30698
Product ID: 30698-493_9ffcac9b-b70e-40ec-a258-9d739771bdba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ergocalciferol
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Validus Pharmaceuticals LLC
Application: NDA003444
Marketing category: NDA
Marketing start: 2018-04-01
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	30698-493	30698-493-01	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
N003444-001	DRISDOL	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RLD, 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
N003444-001	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	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N003444-001	DRISDOL	50,000 IU	CAPSULE / ORAL	AA	RLD, RS, 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	N003444-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N003444-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N003444-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N003444-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N003444-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N003444-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N003444-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N003444-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N003444-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N003444-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N003444-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N003444-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N003444-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N003444-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N003444-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N003444-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N003444-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N003444-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N003444-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N003444-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N003444-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N003444-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N003444-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N003444-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N003444-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N003444-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N003444-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N003444-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N003444-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N003444-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N003444-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N003444-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N003444-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N003444-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N003444-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N003444-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N003444-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N003444-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N003444-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N003444-001	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
30698-493-01	2023-05-09	C162847	48780-1	f386c649-a156-0266-e053-dadaa90a7c1a	Drisdol
30698-493-01	2023-01-30	C162847	48780-1	f386c649-a156-0266-e053-dadaa90a7c1a	Drisdol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
30698-493-01	DRISDOL	100 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
30698-493-01	EA - Each	30698-493	f8b74306-b2bb-471b-9abb-0611c09dae92	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
30698-493	DRISDOL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [VALIDUS PHARMACEUTICALS LLC]	5	Legacy NDC, 1 package rows	20230510_acb61678-d23d-405d-8c14-1a16cfd3a776.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	Torrent Pharmaceuticals Limited	4ae38744-020d-4c37-a6f1-88f55c2f1047	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 003444 application number: NDA003444

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
1367416	Drisdol 1.25 MG (50,000 UNT) Oral Capsule	PSN	acb61678-d23d-405d-8c14-1a16cfd3a776	5
1367410	ergocalciferol 1.25 MG (50,000 UNT) Oral Capsule	PSN	acb61678-d23d-405d-8c14-1a16cfd3a776	5
1367416	ergocalciferol 1.25 MG Oral Capsule [Drisdol]	SBD	acb61678-d23d-405d-8c14-1a16cfd3a776	5
1367410	ergocalciferol 1.25 MG Oral Capsule	SCD	acb61678-d23d-405d-8c14-1a16cfd3a776	5
1367416	Drisdol 1.25 MG (vitamin D2 50,000 UNT) Oral Capsule	SY	acb61678-d23d-405d-8c14-1a16cfd3a776	5
1367416	Drisdol 1.25 MG Oral Capsule	SY	acb61678-d23d-405d-8c14-1a16cfd3a776	5
1367416	Drisdol 50000 UNT Oral Capsule	SY	acb61678-d23d-405d-8c14-1a16cfd3a776	5
1367410	vit-D 1.25 MG Oral Capsule	SY	acb61678-d23d-405d-8c14-1a16cfd3a776	5
1367416	vit-D 1.25 MG Oral Capsule [Drisdol]	SY	acb61678-d23d-405d-8c14-1a16cfd3a776	5
1367410	vitamin D 1.25 MG Oral Capsule	SY	acb61678-d23d-405d-8c14-1a16cfd3a776	5
1367416	vitamin D 1.25 MG Oral Capsule [Drisdol]	SY	acb61678-d23d-405d-8c14-1a16cfd3a776	5
1367410	vitamin D2 1250 MCG Oral Capsule	SY	acb61678-d23d-405d-8c14-1a16cfd3a776	5
1367410	vitamin D2 50,000 UNT Oral Capsule	SY	acb61678-d23d-405d-8c14-1a16cfd3a776	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
30698-493-01	30698049301	100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (30698-493-01)	2018-04-01	0000-00-00	No	No	Current