Promethazine Hydrochloride

Product NDC
50383-801
11-digit product format
503830801
Labeler code
50383
Product ID
50383-801_a3856e47-6212-4526-ae17-089fe6b44675
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA040026
Marketing category
ANDA
Marketing start
1998-09-25
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
6 mg/5mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50383-801IInactivated by FDA2026-10-05
excluded packagepackage50383-80150383-801-04DDiscontinued by firm2026-10-05
excluded packagepackage50383-80150383-801-08DDiscontinued by firm2026-10-05
excluded packagepackage50383-80150383-801-16IInactivated by FDA2026-10-05

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 · 54 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-801-08DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-801-04DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-801-16IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-801-08DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-801-04DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-801-16IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-801-08DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-801-04DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-801-16IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-801-08DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-801-04DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-801-16IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-801-08DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-801-04DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-801-16IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-801-08DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-801-04DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-801-16IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-801-08DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-801-04DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-801-16IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-801-08DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-801-04DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-801-16IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-801-08DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-801-04DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-801-16IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-801-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-801-04DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-801-16IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50383-801-08DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50383-801-04DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50383-801-16IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50383-801-08DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50383-801-04DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50383-801-16IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50383-801-16IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50383-801-16IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50383-801-16IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040026-001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040026-001AA

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-2584e616aacf4f…
2026-08-18 06:07:402026-07A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-253f01610625f2…
2019-09-15 20:21 UTC2019-09A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A040026-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A040026-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040026-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040026-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040026-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040026-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040026-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040026-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040026-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040026-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040026-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040026-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040026-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040026-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040026-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040026-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040026-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040026-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040026-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040026-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040026-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040026-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040026-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040026-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040026-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040026-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040026-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040026-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040026-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040026-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040026-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040026-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040026-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040026-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040026-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040026-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040026-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040026-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040026-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040026-001AA1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-801-04Promethazine Hydrochloride118 mL in 1 BOTTLESOLUTION1189
50383-801-08Promethazine Hydrochloride237 mL in 1 BOTTLESOLUTION2379
50383-801-16Promethazine Hydrochloride473 mL in 1 BOTTLESOLUTION4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-801-16ML - Milliliter50383-801bcd81ec9-9c54-4dfc-86ed-46813686d0f712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-801PROMETHAZINE HYDROCHLORIDE SOLUTION [AKORN]9Legacy NDC, 3 package rows20221015_bd8d1f9a-242c-440b-a5eb-a50f64a1c1d9.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell RX, LLC2ca17cd4-460e-4d54-8c53-a58a2b80e5cb2026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040026
application number: ANDA040026
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.e5d2156d-1f66-4fdf-a3ae-5e1325218c8b2025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040026
application number: ANDA040026

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNbd8d1f9a-242c-440b-a5eb-a50f64a1c1d99
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDbd8d1f9a-242c-440b-a5eb-a50f64a1c1d99
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSYbd8d1f9a-242c-440b-a5eb-a50f64a1c1d99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-801-0450383080104118 mL in 1 BOTTLE (50383-801-04) 118 ml1998-09-250000-00-00NoNoCurrent
50383-801-0850383080108237 mL in 1 BOTTLE (50383-801-08) 237 ml1998-09-250000-00-00NoNoCurrent
50383-801-1650383080116473 mL in 1 BOTTLE (50383-801-16) 473 ml1998-09-250000-00-00NoNoCurrent