FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
68071-4424
11-digit product format
680714424
Labeler code
68071
Product ID
68071-4424_2b36ea69-71a4-dc30-e063-6394a90a13f3
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
2026-12-31
Current FDA listing
Yes

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-4424-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-4424-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-4424-6ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-4424-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-4424-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-4424-6367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-4424-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-4424-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-4424-6557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4424-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4424-48af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4424-68af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4424-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4424-4834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4424-6834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4424-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4424-41332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4424-61332a3947898…d4bfe170f9cd…

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.

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 UTC2026-02A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040712-002PROMETHAZINE HYDROCHLORIDE12.5MGTABLET / ORALAB2007-05-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040712-003PROMETHAZINE HYDROCHLORIDE50MGTABLET / ORALAB2006-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040712-001PROMETHAZINE HYDROCHLORIDE25MGTABLET / ORALAB2006-07-318072bd15b7f6…

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 UTC2026-02A040712-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040712-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040712-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040712-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040712-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040712-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040712-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040712-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040712-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040712-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040712-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040712-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040712-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040712-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040712-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040712-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040712-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040712-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040712-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040712-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040712-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040712-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040712-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040712-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040712-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040712-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040712-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040712-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040712-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040712-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040712-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040712-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040712-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040712-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040712-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040712-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040712-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040712-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040712-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040712-001AB18072bd15b7f6…

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
6bcaa89f-5f14-dc45-e053-2a91aa0aac54Available 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, Related label table
NDCEffectiveRelated label
68071-4424-12025-01-08PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-12025-01-08PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-42025-01-08PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-42025-01-08PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-62025-01-08PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-62025-01-08PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-12023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-12023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-42023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-42023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-62023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-62023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-12021-02-16PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-12021-02-16PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-42021-02-16PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-42021-02-16PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-62021-02-16PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-62021-02-16PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-12021-01-29PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-12021-01-29PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-42021-01-29PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-42021-01-29PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-62021-01-29PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-62021-01-29PROMETHAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4424-1PROMETHAZINE HYDROCHLORIDE10 in 1 BOTTLETABLET103
68071-4424-4PROMETHAZINE HYDROCHLORIDE4 in 1 BOTTLETABLET43
68071-4424-6PROMETHAZINE HYDROCHLORIDE6 in 1 BOTTLETABLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4424PROMETHAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 3 package rows20250110_6bcaa89f-5f14-dc45-e053-2a91aa0aac54.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 · 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
ndc (product): 68071-4424
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.804e2525-d61f-7bed-e053-2991aa0a5daa2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040712
application number: ANDA040712
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN6bcaa89f-5f14-dc45-e053-2a91aa0aac543
992447promethazine hydrochloride 25 MG Oral TabletSCD6bcaa89f-5f14-dc45-e053-2a91aa0aac543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4424-16807144240110 TABLET in 1 BOTTLE (68071-4424-1) 10 tablet2018-05-090000-00-00NoNoCurrent
68071-4424-4680714424044 TABLET in 1 BOTTLE (68071-4424-4) 4 tablet2018-05-090000-00-00NoNoCurrent
68071-4424-6680714424066 TABLET in 1 BOTTLE (68071-4424-6) 6 tablet2018-05-090000-00-00NoNoCurrent