ASTONEAGRAN

Product NDC: 77338-021
Requested package NDC: 77338-021-23
11-digit product format: 773380021
Labeler code: 77338
Product ID: 77338-021_ef04de0d-b002-7219-e053-2a95a90a76f4
Type: HUMAN OTC DRUG
Nonproprietary name: Aluminium Hydroxide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: ASTONEA LABS PRIVATE LIMITED
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-08-17
Marketing end: 0000-00-00
Substance: ALUMINUM HYDROXIDE
Active strength: 2 g/100g
NDC exclude flag: No
Listing certified through: 2023-12-31
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	77338-021	77338-021-23	I	Inactivated by FDA		2026-08-11

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-021	77338-021-23	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-021	77338-021-23	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-021	77338-021-23	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77338-021-23	2024-06-25	C162847	48780-1	1030e365-27e7-111a-e063-dadaa90a10e2	ASTONEA Gran
77338-021-23	2024-01-30	C162847	48780-1	1030e365-27e7-111a-e063-dadaa90a10e2	ASTONEA Gran

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-021-23	ASTONEAGRAN	113 g in 1 TUBE	OINTMENT	113		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-021	ASTONEAGRAN (ALUMINIUM HYDROXIDE) OINTMENT [ASTONEA LABS PRIVATE LIMITED]	3	Legacy NDC, 1 package rows	20240627_e687a337-e87b-815c-e053-2995a90aeaff.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QB0T2IUN0	ALUMINUM HYDROXIDE	21645-51-2	ALUMINUM HYDROXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77338-021-23	77338002123	113 g in 1 TUBE (77338-021-23)	113 g	2022-08-18	0000-00-00	No	No	Current