Promethazine Hydrochloride

Product NDC
67046-374
Requested package NDC
67046-374-30
11-digit product format
670460374
Labeler code
67046
Product ID
67046-374_a906d60d-1e29-26d8-e053-2a95a90a582f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA091179
Marketing category
ANDA
Marketing start
2011-03-03
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
2021-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67046-37467046-374-30IInactivated by FDA2026-08-11

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091179-001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-13
A091179-002PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-13
A091179-003PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091179-001AB
A091179-002AB
A091179-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091179-002PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2010-12-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091179-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2010-12-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091179-001PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2010-12-138072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091179-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091179-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091179-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091179-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091179-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091179-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091179-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091179-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091179-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091179-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091179-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091179-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091179-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091179-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091179-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091179-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091179-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091179-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091179-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091179-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091179-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091179-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091179-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091179-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091179-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091179-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091179-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091179-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091179-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091179-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091179-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091179-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091179-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091179-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091179-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091179-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091179-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091179-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091179-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091179-001AB18072bd15b7f6…

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-374-302022-01-28C16284748780-1d6a99b39-5b6e-a426-e053-dadaa90af4c2PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-374-30Promethazine Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-374PROMETHAZINE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20200627_a9075029-7a39-3b41-e053-2995a90a30a9.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsbf951b5b-6e38-44a9-895e-0d60c6b9d3432026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091179
application number: ANDA091179
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.81fd29a9-c090-49ba-8b48-bd3656ca0c922026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091179
application number: ANDA091179
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLC075f052e-7f38-7f75-e063-6394a90a512b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091179
application number: ANDA091179
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCba4ec2d8-1da4-473b-9ef8-57051cb2c0f72025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091179
application number: ANDA091179
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC0b5734b8-6a52-44ff-ac29-9a91a43353942025-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091179
application number: ANDA091179
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECardinal Health 107, LLCe16238dc-9292-49ac-b80f-8afeccb88bc52025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091179
application number: ANDA091179
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMajor Pharmaceuticals4cee8622-7d59-4794-8e32-54f7aac1d9232025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091179
application number: ANDA091179
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.12400c65-f93b-47a5-8167-1fb14337130b2025-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091179
application number: ANDA091179
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals LLC05907a49-537f-4bf2-8a5f-5e905f19fece2024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091179
application number: ANDA091179

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSNa9075029-7a39-3b41-e053-2995a90a30a91
992447promethazine hydrochloride 25 MG Oral TabletSCDa9075029-7a39-3b41-e053-2995a90a30a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-374-306704603743030 TABLET in 1 BLISTER PACK (67046-374-30) 30 tablet2011-03-030000-00-00NoNoCurrent