PROMETHAZINE HYDROCHLORIDE

Product NDC: 55700-221
Requested package NDC: 55700-221-90
11-digit product format: 557000221
Labeler code: 55700
Product ID: 55700-221_d2e795b9-fdb9-4aef-962e-93c87eec99ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: promethazine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products LLC
Application: ANDA040712
Marketing category: ANDA
Marketing start: 2014-07-09
Marketing end: 0000-00-00
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	55700-221	55700-221-90	D	Discontinued by firm		2026-08-07

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040712-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31
A040712-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04
A040712-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040712-001	AB
A040712-002	AB
A040712-003	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 4 · 123 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	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A040712-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040712-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040712-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040712-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-221-05	EA - Each	55700-221	0905797e-2615-4abf-a838-76f961912e50	1	2016-05-16
55700-221-10	EA - Each	55700-221	98dc4bad-4a9f-4fc0-bdc1-89ecf5d1cd4e	1	2016-05-16
55700-221-12	EA - Each	55700-221	89322c3a-ac8d-4952-952d-300d3725fd89	1	2016-05-16
55700-221-15	EA - Each	55700-221	23d6e9ab-182f-4580-bbe0-9d2c2b03c8ec	1	2016-05-16
55700-221-16	EA - Each	55700-221	9ac3ab11-1448-4ae9-8b5e-fedade03bd75	1	2016-05-16
55700-221-20	EA - Each	55700-221	b8b1bcf2-6ec1-4c69-b042-46b90e358cff	1	2016-05-16
55700-221-30	EA - Each	55700-221	4c4699f7-9cbc-4f2c-a154-eb3685ff7ee5	1	2016-05-16
55700-221-60	EA - Each	55700-221	93c59129-9f66-4ca8-b7ef-68357a202ca5	1	2016-05-16
55700-221-90	EA - Each	55700-221	dcc7311b-e53b-4bce-b538-824ce562d305	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-221	PROMETHAZINE HYDROCHLORIDE TABLET [QUALITY CARE PRODUCTS LLC]	11	Legacy NDC	20250101_004c4371-e4dc-4d79-8b05-aa2efea49043.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6bcaa89f-5f14-dc45-e053-2a91aa0aac54	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	804e2525-d61f-7bed-e053-2991aa0a5daa	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f93ca67d-362a-473f-8296-2952da77c074	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	KVK-Tech, Inc.	7a137adf-39b7-4b14-80da-c3cac9ad562a	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	d9cb1a44-d646-d9e9-e053-2995a90a24ff	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7e5715cf-056f-4095-e053-2991aa0ad3e5	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	a7b1e8b2-6f20-4096-87c7-cf349ed4f7b9	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b54439a3-1d01-4c5f-8508-731790ae215b	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b96904e7-cc67-4abc-b946-8423f3f897ff	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	2c9a4767-23c4-4a1c-bb4c-2bad1351c270	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
Promethazine	PROMETHAZINE	PharmPak, Inc.	4f681538-7ac4-484c-9e6d-b571d73b9e0b	2022-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	29a8b172-1bad-40db-8d73-1fe7fb309cff	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712

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
55700-221-90	55700022190	90 TABLET in 1 BOTTLE (55700-221-90)	90 tablet	2015-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	Quality Care Products LLC	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL	11