Promethazine Hydrochloride

Product NDC: 70752-138
11-digit product format: 707520138
Labeler code: 70752
Product ID: 70752-138_63b61b41-3490-4c96-a50d-778498b51899
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: QUAGEN PHARMACEUTICALS LLC
Application: ANDA213890
Marketing category: ANDA
Marketing start: 2021-07-12
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 6.25 mg/5mL
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 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
A213890-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA		2021-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213890-001	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.

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	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213890-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2021-07-12	`a50c72e98297…`

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	A213890-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213890-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213890-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213890-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213890-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213890-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213890-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213890-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213890-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213890-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213890-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213890-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213890-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213890-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213890-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213890-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213890-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213890-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213890-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213890-001	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213890-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213890-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213890-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213890-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213890-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213890-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213890-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213890-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213890-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213890-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213890-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213890-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213890-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213890-001	AA	1	`a50c72e98297…`

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	6.25 mg/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992432	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
32022e66-6f76-430a-8ad2-1e9e2872fee1	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
2e7222fb-e3f1-febd-962f-ddbb495d6b5f	Product name	2	20220126
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
4f881de7-085a-407e-abc2-faa3c0127432	Product name	1	20170811
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70752-138-06	2023-02-15	Promethazine Hydrochloride Oral Solution, USP 6.25 mg/5 mL Rx only
70752-138-12	2023-02-15	Promethazine Hydrochloride Oral Solution, USP 6.25 mg/5 mL Rx only
70752-138-06	2023-01-30	Promethazine Hydrochloride Oral Solution, USP 6.25 mg/5 mL Rx only
70752-138-12	2023-01-30	Promethazine Hydrochloride Oral Solution, USP 6.25 mg/5 mL Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70752-138-06	Promethazine Hydrochloride	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118		4
70752-138-12	Promethazine Hydrochloride	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70752-138-12	ML - Milliliter	70752-138	ea3a183e-c77c-4be6-898b-5f49537dd795	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70752-138	PROMETHAZINE HYDROCHLORIDE SOLUTION [QUAGEN PHARMACEUTICALS LLC]	4	Current NDC, Legacy NDC, 2 package rows	20230217_32022e66-6f76-430a-8ad2-1e9e2872fee1.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
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	07914b6e-c40f-44be-a1db-8724c70f99b6	2024-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213890 application number: ANDA213890
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	QUAGEN PHARMACEUTICALS LLC	32022e66-6f76-430a-8ad2-1e9e2872fee1	2023-02-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213890 application number: ANDA213890 ndc (product): 70752-138

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
992432	promethazine HCl 6.25 MG in 5 mL Oral Solution	PSN	07914b6e-c40f-44be-a1db-8724c70f99b6	101
992432	promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	07914b6e-c40f-44be-a1db-8724c70f99b6	101
992432	promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	07914b6e-c40f-44be-a1db-8724c70f99b6	101
992432	promethazine HCl 6.25 MG in 5 mL Oral Solution	PSN	32022e66-6f76-430a-8ad2-1e9e2872fee1	4
992432	promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	32022e66-6f76-430a-8ad2-1e9e2872fee1	4
992432	promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	32022e66-6f76-430a-8ad2-1e9e2872fee1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70752-138-06	70752013806	118 mL in 1 BOTTLE, PLASTIC (70752-138-06)	118 ml	2021-07-12	0000-00-00	No	No	Current
70752-138-12	70752013812	473 mL in 1 BOTTLE, PLASTIC (70752-138-12)	473 ml	2021-07-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride Oral Solution, USP 6.25 mg/5 mL Rx only	Bryant Ranch Prepack	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	101
Promethazine Hydrochloride Oral Solution, USP 6.25 mg/5 mL Rx only	QUAGEN PHARMACEUTICALS LLC	2023-02-15	HUMAN PRESCRIPTION DRUG LABEL	4