FDA.reportPublic FDA data

promethazine hydrochloride

Product NDC
57664-109
11-digit product format
576640109
Labeler code
57664
Product ID
57664-109_61563305-2f6b-e520-e053-2a91aa0a15c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA040863
Marketing category
ANDA
Marketing start
2009-01-27
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-109DDiscontinued by firm2026-10-05
excluded packagepackage57664-10957664-109-08DDiscontinued by firm2026-10-05
excluded packagepackage57664-10957664-109-13DDiscontinued by firm2026-10-05
excluded packagepackage57664-10957664-109-18DDiscontinued by firm2026-10-05
excluded packagepackage57664-10957664-109-83DDiscontinued by firm2026-10-05
excluded packagepackage57664-10957664-109-88DDiscontinued by firm2026-10-05

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 2 · 72 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-109-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-109-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-109-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-109-83d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-109-18d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-109-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-109-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-109-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-109-83f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-109-18f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-109-882ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-109-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-109-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-109-832ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-109-182ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-109-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-109-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-109-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-109-83a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-109-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-109-88cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-109-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-109-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-109-83cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-109-18cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-109-88cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-109-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-109-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-109-83cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-109-18cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-109-88302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-109-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-109-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-109-83302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-109-18302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-109-88ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-109-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-109-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-109-83ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-109-18ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-109-880efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-109-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-109-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-109-830efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-109-180efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-109-88ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-109-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-109-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-109-83ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-109-18ad56d346431e…cc804d4bbf1e…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040863-001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-30
A040863-002PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-30
A040863-003PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-30

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-3084e616aacf4f…
2026-09-14 22:38:342026-08A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-3084e616aacf4f…
2026-09-14 22:38:342026-08A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-3084e616aacf4f…
2026-08-18 06:07:402026-07A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040863-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040863-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040863-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORAL2008-12-30301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040863-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040863-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040863-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040863-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040863-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040863-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040863-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040863-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040863-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040863-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040863-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040863-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040863-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040863-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040863-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040863-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040863-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040863-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040863-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040863-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040863-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040863-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040863-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040863-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040863-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040863-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040863-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040863-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040863-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040863-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040863-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040863-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040863-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040863-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040863-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040863-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040863-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040863-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040863-003AB1ea99ee380514…
2023-12-20 04:57 UTC2023-12A040863-001AB1ea1830bbd6c7…

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
57664-109-082020-09-14cb5950f9-dc5a-4a30-9f3e-08b006f27dd5
57664-109-132020-09-14cb5950f9-dc5a-4a30-9f3e-08b006f27dd5
57664-109-182020-09-14cb5950f9-dc5a-4a30-9f3e-08b006f27dd5
57664-109-832020-09-14cb5950f9-dc5a-4a30-9f3e-08b006f27dd5
57664-109-882020-09-14cb5950f9-dc5a-4a30-9f3e-08b006f27dd5
57664-109-082020-07-22cb5950f9-dc5a-4a30-9f3e-08b006f27dd5
57664-109-132020-07-22cb5950f9-dc5a-4a30-9f3e-08b006f27dd5
57664-109-182020-07-22cb5950f9-dc5a-4a30-9f3e-08b006f27dd5
57664-109-832020-07-22cb5950f9-dc5a-4a30-9f3e-08b006f27dd5
57664-109-882020-07-22cb5950f9-dc5a-4a30-9f3e-08b006f27dd5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-109-88EA - Each57664-1093a3cdacb-7248-48b1-b087-72c6db921e9812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMETHAZINE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPROMETHAZINE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPROMETHAZINE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROMETHAZINE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992438promethazine HCl 12.5 MG Oral TabletPSNff1dddab-72a0-4125-859e-554bece2d2b31
992447promethazine HCl 25 MG Oral TabletPSNff1dddab-72a0-4125-859e-554bece2d2b31
992475promethazine HCl 50 MG Oral TabletPSNff1dddab-72a0-4125-859e-554bece2d2b31
992438promethazine hydrochloride 12.5 MG Oral TabletSCDff1dddab-72a0-4125-859e-554bece2d2b31
992447promethazine hydrochloride 25 MG Oral TabletSCDff1dddab-72a0-4125-859e-554bece2d2b31
992475promethazine hydrochloride 50 MG Oral TabletSCDff1dddab-72a0-4125-859e-554bece2d2b31