FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
68071-4737
Requested package NDC
68071-4737-6
11-digit product format
680714737
Labeler code
68071
Product ID
68071-4737_50289e7b-d122-11a1-e063-6394a90ac840
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040712
Marketing category
ANDA
Marketing start
2006-07-31
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A040712-001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-31
A040712-002PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-04
A040712-003PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040712-001AB
A040712-002AB
A040712-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-31a50c72e98297…
2026-08-01 22:54:322026-06A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-04a50c72e98297…
2026-08-01 22:54:322026-06A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040712-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A040712-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A040712-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.6bcaa89f-5f14-dc45-e053-2a91aa0aac542026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.804e2525-d61f-7bed-e053-2991aa0a5daa2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
ndc (package): 68071-4737-6
ndc (product): 68071-4737
ndc11 (package): 68071473706
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepacke6d940f8-fa1a-4a75-b4fc-2cbbaf7a04882026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackf9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c472026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5ce082e9-13eb-4e63-a9e2-657d3ef0e9f82026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f93ca67d-362a-473f-8296-2952da77c0742026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEKVK-Tech, Inc.7a137adf-39b7-4b14-80da-c3cac9ad562a2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCd9cb1a44-d646-d9e9-e053-2995a90a24ff2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7e5715cf-056f-4095-e053-2991aa0ad3e52024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsa7b1e8b2-6f20-4096-87c7-cf349ed4f7b92023-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsb54439a3-1d01-4c5f-8508-731790ae215b2023-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsb96904e7-cc67-4abc-b946-8423f3f897ff2023-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutions2c9a4767-23c4-4a1c-bb4c-2bad1351c2702023-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PromethazinePROMETHAZINEPharmPak, Inc.4f681538-7ac4-484c-9e6d-b571d73b9e0b2022-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEProficient Rx LP29a8b172-1bad-40db-8d73-1fe7fb309cff2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712

Additional Listing Data#

Finished product
Yes
Brand name base
PROMETHAZINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R61ZEH7I1IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992447Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
804e2525-d61f-7bed-e053-2991aa0a5daaAvailable on FDA.report

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
68071-4737-62024-06-12C16284748780-1ba0f9c33-2ed7-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4737-62024-06-12C16284748780-1ba0f9c33-2ed7-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4737-62023-01-30C16284748780-1ba0f9c33-2ed7-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4737-62023-01-30C16284748780-1ba0f9c33-2ed7-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4737-62021-02-17C16284748780-1ba0f9c33-2ed7-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4737-62021-02-17C16284748780-1ba0f9c33-2ed7-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4737-62021-01-29C16284748780-1ba0f9c33-2ed7-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4737-62021-01-29C16284748780-1ba0f9c33-2ed7-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4737-3PROMETHAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET304
68071-4737-6PROMETHAZINE HYDROCHLORIDE6 in 1 BOTTLETABLET64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4737PROMETHAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 2 package rows20240614_804e2525-d61f-7bed-e053-2991aa0a5daa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN804e2525-d61f-7bed-e053-2991aa0a5daa4
992447promethazine hydrochloride 25 MG Oral TabletSCD804e2525-d61f-7bed-e053-2991aa0a5daa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4737-6680714737066 TABLET in 1 BOTTLE (68071-4737-6) 6 tablet2019-01-250000-00-00NoNoCurrent