Promethazine Hydrochloride

Product NDC: 45802-759
11-digit product format: 458020759
Labeler code: 45802
Product ID: 45802-759_14ed3375-f9ec-40bf-8529-cafc44c46f28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA040500
Marketing category: ANDA
Marketing start: 2006-05-17
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
A040500-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-06-30
A040500-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB		2003-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040500-001	AB
A040500-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`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	A040500-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040500-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040500-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040500-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040500-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040500-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040500-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040500-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040500-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040500-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040500-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040500-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040500-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040500-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040500-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040500-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040500-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040500-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040500-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040500-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040500-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040500-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040500-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040500-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040500-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040500-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040500-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040500-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040500-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040500-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040500-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040500-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040500-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040500-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040500-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040500-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040500-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040500-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040500-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040500-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Promethazine Hydrochloride
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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992441	Internal RxNorm lookup
992454	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
047b9a7c-586b-4635-a63e-2c7ce9ec34e7	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	Strength	SPL version
45802-759-00	Promethazine Hydrochloride	1 in 1 BLISTER PACK	SUPPOSITORY	1		16
45802-759-30	Promethazine Hydrochloride	12 in 1 CARTON	SUPPOSITORY	12		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-759-00	EA - Each	45802-759	746555d8-d089-4d29-a28c-93926f76a561	1	2015-03-03
45802-759-30	EA - Each	45802-759	56ac9144-d794-49de-ad4a-1141c6e43e61	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]	5
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]	5
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]	5
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]	5
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]	5
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	3
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	3
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	3
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	3
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]	3
Promethazine Hydrochloride	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]	1
Promethazine	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]	1
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]	1
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-759	PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PADAGIS ISRAEL PHARMACEUTICALS LTD]	16	Current NDC, Legacy NDC, 2 package rows	20250522_047b9a7c-586b-4635-a63e-2c7ce9ec34e7.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	46b869e2-9305-43ae-bb15-919a6d09b6ff	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040500 application number: ANDA040500
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7d766cf7-a21c-4eaf-bbdc-00f2939ef19a	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040500 application number: ANDA040500
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Asclemed USA, Inc.	1b1cee64-c0b5-4da6-92d0-1769350a5181	2025-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040500 application number: ANDA040500
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	047b9a7c-586b-4635-a63e-2c7ce9ec34e7	2023-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040500 application number: ANDA040500 ndc (product): 45802-759

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992441	promethazine HCl 12.5 MG Rectal Suppository	PSN	46b869e2-9305-43ae-bb15-919a6d09b6ff	22
992454	promethazine HCl 25 MG Rectal Suppository	PSN	46b869e2-9305-43ae-bb15-919a6d09b6ff	22
992441	promethazine hydrochloride 12.5 MG Rectal Suppository	SCD	46b869e2-9305-43ae-bb15-919a6d09b6ff	22
992454	promethazine hydrochloride 25 MG Rectal Suppository	SCD	46b869e2-9305-43ae-bb15-919a6d09b6ff	22
992454	promethazine HCl 25 MG Rectal Suppository	PSN	7d766cf7-a21c-4eaf-bbdc-00f2939ef19a	18
992454	promethazine hydrochloride 25 MG Rectal Suppository	SCD	7d766cf7-a21c-4eaf-bbdc-00f2939ef19a	18
992441	promethazine HCl 12.5 MG Rectal Suppository	PSN	047b9a7c-586b-4635-a63e-2c7ce9ec34e7	16
992454	promethazine HCl 25 MG Rectal Suppository	PSN	047b9a7c-586b-4635-a63e-2c7ce9ec34e7	16
992441	promethazine hydrochloride 12.5 MG Rectal Suppository	SCD	047b9a7c-586b-4635-a63e-2c7ce9ec34e7	16
992454	promethazine hydrochloride 25 MG Rectal Suppository	SCD	047b9a7c-586b-4635-a63e-2c7ce9ec34e7	16
992441	promethazine HCl 12.5 MG Rectal Suppository	PSN	1b1cee64-c0b5-4da6-92d0-1769350a5181	1
992454	promethazine HCl 25 MG Rectal Suppository	PSN	1b1cee64-c0b5-4da6-92d0-1769350a5181	1
992454	promethazine HCl 25 MG Rectal Suppository	PSN	3087a1cb-fda5-4115-86b6-1cce480a2f8e	1
992441	promethazine hydrochloride 12.5 MG Rectal Suppository	SCD	1b1cee64-c0b5-4da6-92d0-1769350a5181	1
992454	promethazine hydrochloride 25 MG Rectal Suppository	SCD	1b1cee64-c0b5-4da6-92d0-1769350a5181	1
992454	promethazine hydrochloride 25 MG Rectal Suppository	SCD	3087a1cb-fda5-4115-86b6-1cce480a2f8e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-759-00	45802075900	1 in 1 BLISTER PACK						Historical
45802-759-30	45802075930	12 BLISTER PACK in 1 CARTON (45802-759-30) / 1 SUPPOSITORY in 1 BLISTER PACK (45802-759-00)	12 blister pack	2006-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg	A-S Medication Solutions	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	22
Promethazine Hydrochloride Suppositories USP, 25 mg	PD-Rx Pharmaceuticals, Inc.	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	18
Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-06-07	HUMAN PRESCRIPTION DRUG LABEL	1
Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg	Bryant Ranch Prepack	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	103
Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg	Padagis Israel Pharmaceuticals Ltd	2023-06-30	HUMAN PRESCRIPTION DRUG LABEL	16
Promethazine Hydrochloride Suppositories, USP 25 mg	Rebel Distributors Corp	2010-11-11	HUMAN PRESCRIPTION DRUG LABEL	1