38779-0325-9

Product NDC: 38779-0325
Requested package NDC: 38779-0325-9
11-digit product format: 387790325
Labeler code: 38779
Product ID: 38779-0325_4391fa01-00d0-a977-e063-6394a90a6363
Type: BULK INGREDIENT
Nonproprietary name: Cimetidine
Dosage form: POWDER
Marketing category: BULK INGREDIENT
Marketing start: 2012-12-21
Substance: CIMETIDINE
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	38779-0325	38779-0325-9	UNFINISHED	Active or certified unfinished drug listing		2026-10-05

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
CIMETIDINE	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
38779-0325-3	GM - Gram	38779-0325	ef45e377-e402-4137-b8f3-3bf5da9335aa	1	2013-02-19
38779-0325-4	GM - Gram	38779-0325	a5e8f803-1b14-4af8-bc08-c2d66fcc1935	1	2013-02-19
38779-0325-5	GM - Gram	38779-0325	dd5422d9-9b87-475c-9916-2fcc221eaf18	1	2013-02-19
38779-0325-7	GM - Gram	38779-0325	423f9ea4-0319-4a25-9bdf-aeb17a2ee474	1	2013-08-02
38779-0325-8	GM - Gram	38779-0325	efcceb79-c2dc-4c23-9ff0-4b00a7c02a75	1	2013-02-19
38779-0325-9	GM - Gram	38779-0325	11b3c659-b130-4228-90e9-fef536be3d84	1	2013-02-19

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
80061L1WGD	CIMETIDINE	51481-61-9	CIMETIDINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
38779-0325-9	38779032509	1000 g in 1 JAR (38779-0325-9)	1000 g	21-DEC-12	Current