Promethazine Hydrochloride

Product NDC: 68788-8162
11-digit product format: 687888162
Labeler code: 68788
Product ID: 68788-8162_feee6de7-a830-4b36-832f-1983b282a970
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA040643
Marketing category: ANDA
Marketing start: 2022-04-04
Marketing end: 0000-00-00
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 6 mg/5mL
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68788-8162		D	Discontinued by firm		2026-08-17
excluded package	package	68788-8162	68788-8162-4	D	Discontinued by firm		2026-08-17

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-8162-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-8162-4	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040643-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA		2006-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040643-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040643-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040643-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040643-001	AA	1	`31067a03dcf5…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040643-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040643-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040643-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040643-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040643-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040643-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040643-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040643-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040643-001	AA	1	`8869cabd3fbd…`
2019-12-14 00:12 UTC	2019-12	A040643-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040643-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040643-001	AA	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040643-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040643-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040643-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040643-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040643-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040643-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040643-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040643-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040643-001	AA	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8162-4	ML - Milliliter	68788-8162	835ab356-d4f6-4e37-b107-8ef7042ff1db	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8162	PROMETHAZINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS INC.]	3	Legacy NDC	20240805_feee6de7-a830-4b36-832f-1983b282a970.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
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	7a186bcd-ab8c-4695-8289-4cd33bb551cf	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040643 application number: ANDA040643

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE	58-33-3	PROMETHAZINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8162-4	68788816204	473 mL in 1 BOTTLE (68788-8162-4)	473 ml	2022-04-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Plain Oral Solution (Promethazine Hydrochloride Oral Solution)	Preferred Pharmaceuticals Inc.	2024-08-02	HUMAN PRESCRIPTION DRUG LABEL	3