PROMETHEGAN

Product NDC: 55289-928
11-digit product format: 552890928
Labeler code: 55289
Product ID: 55289-928_419b860e-68c0-f896-e063-6294a90aceb9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA040428
Marketing category: ANDA
Marketing start: 2002-02-28
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040428-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05
A040428-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040428-001	AB
A040428-002	AB

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 3 · 82 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	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A040428-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040428-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040428-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040428-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040428-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040428-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040428-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040428-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040428-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040428-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040428-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040428-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040428-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040428-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040428-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040428-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040428-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040428-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040428-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040428-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040428-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040428-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040428-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040428-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040428-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040428-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040428-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040428-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040428-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040428-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040428-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040428-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040428-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040428-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040428-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040428-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040428-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040428-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040428-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040428-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: PROMETHEGAN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R61ZEH7I1I	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3036445d-7d13-4411-a100-f2ac5ab8a276	Product name	1	20240110
2e7222fb-e3f1-febd-962f-ddbb495d6b5f	Product name	2	20220126
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
4f881de7-085a-407e-abc2-faa3c0127432	Product name	1	20170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
d51697af-7f97-0559-95d1-fe94f3f031d5	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55289-928-02	PROMETHEGAN	2 in 1 BOTTLE, PLASTIC	SUPPOSITORY	2	14
55289-928-04	PROMETHEGAN	4 in 1 BOTTLE, PLASTIC	SUPPOSITORY	4	14
55289-928-06	PROMETHEGAN	6 in 1 BOTTLE, PLASTIC	SUPPOSITORY	6	14
55289-928-79	PROMETHEGAN	1 in 1 BOTTLE, PLASTIC	SUPPOSITORY	1	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-928-02	EA - Each	55289-928	ddb0dd20-0307-4a86-8b71-fe07ed4e015b	1	2012-07-24
55289-928-04	EA - Each	55289-928	81693d7a-fa7c-4667-a080-3b27714fc224	1	2012-07-24
55289-928-06	EA - Each	55289-928	149f62a3-ba28-4f76-8eb7-480ab50866ee	1	2012-07-24
55289-928-79	EA - Each	55289-928	ec0e5bfe-9003-4399-9814-af1eb71edfdc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Promethazine Hydrochloride	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	1
Promethazine	ACTIVE MOIETY	FF28EJQ494	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	1
Ascorbyl Palmitate	INACTIVE INGREDIENT	QN83US2B0N	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	1
Fat, Hard	INACTIVE INGREDIENT	8334LX7S21	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	1
White Wax	INACTIVE INGREDIENT	7G1J5DA97F	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55289-928	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	13	Current NDC, Legacy NDC, 4 package rows	20240315_6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97	2025-10-20	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 040428 application number: ANDA040428 ndc (product): 55289-928
PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	5f079815-f48b-8b21-2130-7f791d967c9a	2023-11-30	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 040428 application number: ANDA040428

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
55289-928-02	55289092802	2 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-02)	2 suppository	2011-07-13	0000-00-00	No	No	Current
55289-928-04	55289092804	4 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-04)	4 suppository	2011-07-13	0000-00-00	No	No	Current
55289-928-06	55289092806	6 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-06)	6 suppository	2011-07-13	0000-00-00	No	No	Current
55289-928-79	55289092879	1 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-79)	1 suppository	2011-07-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP Rx Only	PD-Rx Pharmaceuticals, Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	14