VITAMIN D

Product NDC: 50268-297
11-digit product format: 502680297
Labeler code: 50268
Product ID: 50268-297_47e3501c-5ccf-b8af-e063-6294a90a9c4c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ergocalciferol
Dosage form: CAPSULE
Route: ORAL
Labeler: AvPAK
Application: ANDA090455
Marketing category: ANDA
Marketing start: 2020-04-07
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
A090455-001	ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090455-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`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	A090455-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090455-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090455-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090455-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090455-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090455-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090455-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090455-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090455-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090455-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090455-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090455-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090455-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090455-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090455-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090455-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090455-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090455-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090455-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090455-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090455-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090455-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090455-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090455-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090455-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090455-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090455-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090455-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090455-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090455-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090455-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090455-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090455-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090455-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090455-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090455-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090455-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090455-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090455-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090455-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: VITAMIN D
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
a2b82923-f0dd-641f-e053-2995a90a7c4a	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
50268-297-11	VITAMIN D	1 in 1 BLISTER PACK	CAPSULE	1		4
50268-297-15	VITAMIN D	50 in 1 BOX	CAPSULE	50		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-297-11	EA - Each	50268-297	05d4fe12-b245-4409-94bf-0195235f7e82	1	2020-05-08
50268-297-15	EA - Each	50268-297	56296c60-b2ec-4c30-a831-f7361589e7c0	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-297	VITAMIN D (ERGOCALCIFEROL) CAPSULE [AVPAK]	3	Current NDC, Legacy NDC, 2 package rows	20240110_a2b82923-f0dd-641f-e053-2995a90a7c4a.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VITAMIN D	ERGOCALCIFEROL	REMEDYREPACK INC.	3fe92511-0b4a-43f4-9c89-c8599469c1e2	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455
VITAMIN D	ERGOCALCIFEROL	Aphena Pharma Solutions - Tennessee, LLC	3c0f4142-cc1f-43de-8677-ee06b6f4fc10	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455
VITAMIN D	ERGOCALCIFEROL	AvPAK	a2b82923-f0dd-641f-e053-2995a90a7c4a	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455 ndc (product): 50268-297
VITAMIN D	ERGOCALCIFEROL	Northwind Health Company, LLC	f3402462-5d86-b4c9-e053-2a95a90aaab0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455
VITAMIN D	ERGOCALCIFEROL	Preferred Pharmaceuticals, Inc.	ba2076ef-1650-45e1-b092-a4c449dd6210	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455
VITAMIN D	ERGOCALCIFEROL	Golden State Medical Supply, Inc.	26aba724-8990-def9-e063-6394a90a991d	2025-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455
VITAMIN D	ERGOCALCIFEROL	PD-Rx Pharmaceuticals, Inc.	7e9b75e3-eb7c-4227-b953-166ac6897e54	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455
VITAMIN D	ERGOCALCIFEROL	Strides Pharma Science Limited	2c4c0a36-12cf-444d-9d57-de983eef4d36	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455
VITAMIN D	ERGOCALCIFEROL	Bryant Ranch Prepack	a8aa37f4-7e94-4425-beea-49c938294a23	2024-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455
VITAMIN D	ERGOCALCIFEROL	Proficient Rx LP	548365c1-b51c-4a8b-ae3d-50b41aba12db	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455

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	a2b82923-f0dd-641f-e053-2995a90a7c4a	4
1367410	ergocalciferol 1.25 MG Oral Capsule	SCD	a2b82923-f0dd-641f-e053-2995a90a7c4a	4
1367410	vit-D 1.25 MG Oral Capsule	SY	a2b82923-f0dd-641f-e053-2995a90a7c4a	4
1367410	vitamin D 1.25 MG Oral Capsule	SY	a2b82923-f0dd-641f-e053-2995a90a7c4a	4
1367410	vitamin D2 1250 MCG Oral Capsule	SY	a2b82923-f0dd-641f-e053-2995a90a7c4a	4
1367410	vitamin D2 50,000 UNT Oral Capsule	SY	a2b82923-f0dd-641f-e053-2995a90a7c4a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-297-11	50268029711	1 in 1 BLISTER PACK						Historical
50268-297-15	50268029715	50 BLISTER PACK in 1 BOX (50268-297-15) / 1 CAPSULE in 1 BLISTER PACK (50268-297-11)	50 blister pack	2020-04-07	0000-00-00	No	No	Current