PROMETHAZINE HYDROCHLORIDE

Product NDC: 61919-191
11-digit product format: 619190191
Labeler code: 61919
Product ID: 61919-191_b8554ec3-0b02-4534-e053-2a95a90ac152
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROMETHAZINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA083426
Marketing category: ANDA
Marketing start: 2014-01-01
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-191		D	Discontinued by firm	2026-08-17
excluded product	product	61919-191		I	Inactivated by FDA	2026-08-17
excluded package	package	61919-191	61919-191-10	D	Discontinued by firm	2026-08-17
excluded package	package	61919-191	61919-191-12	D	Discontinued by firm	2026-08-17
excluded package	package	61919-191	61919-191-15	D	Discontinued by firm	2026-08-17
excluded package	package	61919-191	61919-191-30	D	Discontinued by firm	2026-08-17
excluded package	package	61919-191	61919-191-60	I	Inactivated by FDA	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 2 · 93 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-191-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-191-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-191-12	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-191-15	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-191-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-191-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-191-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-191-12	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-191-15	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-191-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-191-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-191-10	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-191-12	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-191-15	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-191-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-191-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-191-10	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-191-12	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-191-15	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-191-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-191-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-191-10	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-191-12	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-191-15	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-191-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-191-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-191-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-191-12	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-191-15	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-191-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-191-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-191-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-191-10	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-191-12	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-191-15	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-191-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-191-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-191-10	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-191-12	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-191-15	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-191-30	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-191-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A083426-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A083426-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A083426-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083426-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083426-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083426-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083426-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083426-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083426-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083426-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083426-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083426-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083426-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083426-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083426-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083426-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083426-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083426-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083426-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083426-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083426-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083426-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083426-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083426-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083426-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083426-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083426-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083426-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083426-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083426-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083426-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083426-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083426-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083426-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083426-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083426-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083426-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083426-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083426-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083426-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083426-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083426-001	AB	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-191-60	2025-01-30	2cef2736-776b-d83d-e063-dadaa90ab31f	PROMETHAZINE HYDROCHLORIDE
61919-191-10	2021-01-07	9d75b9cf-ddbd-f424-e053-dadaa90a57ce	PROMETHAZINE HYDROCHLORIDE
61919-191-12	2021-01-07	9d75b9cf-ddbd-f424-e053-dadaa90a57ce	PROMETHAZINE HYDROCHLORIDE
61919-191-15	2021-01-07	9d75b9cf-ddbd-f424-e053-dadaa90a57ce	PROMETHAZINE HYDROCHLORIDE
61919-191-30	2021-01-07	9d75b9cf-ddbd-f424-e053-dadaa90a57ce	PROMETHAZINE HYDROCHLORIDE
61919-191-10	2020-01-31	9d75b9cf-ddbd-f424-e053-dadaa90a57ce	PROMETHAZINE HYDROCHLORIDE
61919-191-12	2020-01-31	9d75b9cf-ddbd-f424-e053-dadaa90a57ce	PROMETHAZINE HYDROCHLORIDE
61919-191-15	2020-01-31	9d75b9cf-ddbd-f424-e053-dadaa90a57ce	PROMETHAZINE HYDROCHLORIDE
61919-191-30	2020-01-31	9d75b9cf-ddbd-f424-e053-dadaa90a57ce	PROMETHAZINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-191-60	PROMETHAZINE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-191-10	EA - Each	61919-191	d40992a0-9645-481d-8547-dad46c1b1c42	1	2019-09-05
61919-191-12	EA - Each	61919-191	09d20a76-253d-4ef9-9b25-8bf2df564bfb	1	2019-08-06
61919-191-30	EA - Each	61919-191	662cd921-f1f3-4e5d-a398-e232b45f867d	1	2015-03-03
61919-191-60	EA - Each	61919-191	9bf3f3cb-bd68-472c-a5f2-16d245aeebc0	1	2019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-191	PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT_RX]	4	Legacy NDC, 1 package rows	20230413_8e0b2adf-12b3-eb4b-e053-2a95a90a41c6.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	Northwind Health Company, LLC	f6ca1097-1c75-c682-e053-6294a90a2bd6	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083426 application number: ANDA083426
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	74834e1b-0d90-0542-e053-2991aa0aa1ef	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083426 application number: ANDA083426
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	08bf9fbf-cc21-41a0-9e81-ec498aa64170	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083426 application number: ANDA083426
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Actavis Pharma, Inc.	a32255f0-0077-489e-bdc6-869aca8cd434	2016-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083426 application number: ANDA083426

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
992447	promethazine HCl 25 MG Oral Tablet	PSN	8e0b2adf-12b3-eb4b-e053-2a95a90a41c6	4
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	8e0b2adf-12b3-eb4b-e053-2a95a90a41c6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-191-10	61919019110	10 TABLET in 1 BOTTLE (61919-191-10)	10 tablet	2015-01-01	0000-00-00	No	No	Current
61919-191-12	61919019112	12 TABLET in 1 BOTTLE (61919-191-12)	12 tablet	2015-01-01	0000-00-00	No	No	Current
61919-191-15	61919019115	15 TABLET in 1 BOTTLE (61919-191-15)	15 tablet	2015-01-01	0000-00-00	No	No	Current
61919-191-30	61919019130	30 TABLET in 1 BOTTLE (61919-191-30)	30 tablet	2015-01-01	0000-00-00	No	No	Current
61919-191-60	61919019160	60 TABLET in 1 BOTTLE (61919-191-60)	60 tablet	2019-07-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE HYDROCHLORIDE	Direct_Rx	2023-04-12	HUMAN PRESCRIPTION DRUG LABEL	4
PROMETHAZINE HYDROCHLORIDE	DIRECT RX	2021-01-07	HUMAN PRESCRIPTION DRUG LABEL	3