38779-1935-9

Product NDC: 38779-1935
Requested package NDC: 38779-1935-9
11-digit product format: 387791935
Labeler code: 38779
Product ID: 38779-1935_43fa3055-27fe-2aa7-e063-6394a90a5ee5
Type: BULK INGREDIENT
Nonproprietary name: Omeprazole
Dosage form: POWDER
Marketing category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Marketing start: 2015-07-06
Substance: OMEPRAZOLE
Active strength: 1 g/g
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
unfinished package	package	38779-1935	38779-1935-9	UNFINISHED	Active or certified unfinished drug listing		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	1 g/g

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
38779-1935-0	GM - Gram	38779-1935	314d978f-63c6-45c6-b0a8-6de0d967877f	1	2014-09-03
38779-1935-1	GM - Gram	38779-1935	392bffb2-f53b-4cf6-b3bc-f738876273d8	1	2018-09-05
38779-1935-2	GM - Gram	38779-1935	90311108-78bd-43b7-88d0-b163f53af4ae	1	2019-01-24
38779-1935-3	GM - Gram	38779-1935	49e88bd1-9137-43fd-ba97-131f3b3ead41	1	2013-02-19
38779-1935-4	GM - Gram	38779-1935	71786d7f-9200-4c1d-9ed5-5984cd467a46	1	2013-02-19
38779-1935-5	GM - Gram	38779-1935	3cb2e6dc-c845-4794-b2a5-5db965892f37	1	2013-02-19
38779-1935-6	GM - Gram	38779-1935	d68855f1-f5a5-4359-b285-d726dd05a23c	1	2018-09-05
38779-1935-7	GM - Gram	38779-1935	c1dc8259-8a8b-4804-a0d5-7dee97d6e1ce	1	2014-09-03
38779-1935-8	GM - Gram	38779-1935	2646549e-3b2c-4f9c-b7ec-07023b6ed014	1	2013-02-19
38779-1935-9	GM - Gram	38779-1935	2737aedd-21bb-4c4e-af65-fa0f3da99cf0	1	2013-02-19

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
38779-1935-9	38779193509	1000 g in 1 JAR (38779-1935-9)	1000 g	06-OCT-17	Current