dextromethorphan polistirex extended release

Product NDC
45802-433
11-digit product format
458020433
Labeler code
45802
Product ID
45802-433_bab41dff-1e5a-44c4-884a-4625c10eda44
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA091135
Marketing category
ANDA
Marketing start
2012-09-10
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/5mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 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
A091135-001DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25

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 22:38:342026-08A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2584e616aacf4f…
2026-08-18 06:07:402026-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-253f01610625f2…
2019-09-15 20:21 UTC2019-09A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
dextromethorphan polistirex extended release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-433-21dextromethorphan polistirex extended release89 mL in 1 BOTTLESUSPENSION896
45802-433-21dextromethorphan polistirex extended release1 in 1 CARTONSUSPENSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-433-21ML - Milliliter45802-433af1113d3-4f00-4a61-8cf1-e110bd462d5e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
POLISTIREXINACTIVE INGREDIENT5H9W9GTW27DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
TRAGACANTHINACTIVE INGREDIENT2944357O2ODEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PERRIGO NEW YORK INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-433DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PADAGIS ISRAEL PHARMACEUTICALS LTD]6Current NDC, Legacy NDC, 2 package rows20250213_7a6b68eb-8fe0-447d-aed7-28432c45b58c.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 2 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough DMDEXTROMETHORPHAN POLISTIREXH E Bf8f225cd-a0f2-4991-828f-cc75497782352025-11-01WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Topcare Cough DMDEXTROMETHORPHAN POLISTIREXTopco Associates LLCd1740816-425d-4327-9cff-6ca5ce430d0c2025-10-31WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Leader Cough DMDEXTROMETHORPHAN POLISTIREXCardinal Health 110, LLC. dba Leader4c99b5e3-cd79-4c54-ae37-3673c836e6682025-10-31WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Cough DMDEXTROMETHORPHAN POLISTIREXPublix Super Markets Inc5a71cad4-8816-47f4-840c-27765d377f0a2025-09-26WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Cough DMDEXTROMETHORPHAN POLISTIREXMeijer Distribution Incfb6fce1e-2dea-485c-be18-c6764454fe252025-09-26WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
cough dm childrensDEXTROMETHORPHAN POLISTIREXMeijer Distribution Inc8af9367e-aa0b-4f9e-a7df-737d5411bc3c2025-06-13WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
cough dmDEXTROMETHORPHAN POLISTIREXATLANTIC BIOLOGICALS CORP.73aede9d-37dd-4aa5-a906-0e0c94cecff12025-05-12WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Cough DMDEXTROMETHORPHAN POLISTIREXMeijer Distribution Inc3febf0e0-b587-495a-9608-3a2dfbc327912025-05-07WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
dextromethorphan polistirex extended releaseDEXTROMETHORPHAN POLISTIREXBryant Ranch Prepackbd415342-90e1-411b-b6c9-652e9532c6112025-04-02WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
dextromethorphan polistirex extended releaseDEXTROMETHORPHAN POLISTIREXPadagis Israel Pharmaceuticals Ltd7a6b68eb-8fe0-447d-aed7-28432c45b58c2025-02-11WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
ndc (product): 45802-433
Cough DMDEXTROMETHORPHAN POLISTIREXCVS Pharmacya9765a9b-3ae3-45bc-ab59-06ec5249e2c92025-02-11WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Robitussin 12 Hour Cough ReliefDEXTROMETHORPHAN POLISTIREXHaleon US Holdings LLC5d12a1b8-f1fb-41ca-9a4f-0595a585cbb52024-04-08WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Childrens Robitussin 12 Hour Cough ReliefDEXTROMETHORPHAN POLISTIREXHaleon US Holdings LLC6bcad434-5714-443c-ba83-ed534df9f20a2024-04-08WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
equaline cough dmDEXTROMETHORPHAN POLISTIREXUnited Natural Foods, Inc. dba UNFI16de32bb-1d02-470b-82b6-9b4366e198172023-07-24WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
signature care 12 hour cough reliefDEXTROMETHORPHAN POLISTIREXSafeway6f8d78f7-b3ec-43d1-a5a6-60a24e9ab8a82023-06-08WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Cough DMDEXTROMETHORPHAN POLISTIREXWalgreen Companybe67fb34-6ecb-4b45-9a67-3f78f4af8e362023-06-06WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Cough DMDEXTROMETHORPHAN POLISTIREXWalgreen Companyc628923a-6771-4aba-9e2d-4795c9effb332023-04-04WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Cough DMDEXTROMETHORPHAN POLISTIREXCVS Pharmacycb71164f-e4bf-48b9-a8b1-f7271d38a5882022-06-29WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
signature care childrens 12 hour cough reliefDEXTROMETHORPHAN POLISTIREXSafeway62d71572-d157-484a-8676-7ce6da413ee82022-06-01WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
basic care cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLC8127c389-c1e3-4f2e-b306-13587b5b50c42021-08-09WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN7a6b68eb-8fe0-447d-aed7-28432c45b58c6
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD7a6b68eb-8fe0-447d-aed7-28432c45b58c6
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY7a6b68eb-8fe0-447d-aed7-28432c45b58c6
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY7a6b68eb-8fe0-447d-aed7-28432c45b58c6
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN8007a226-f0d2-4618-af13-33c807f36ab52
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNbd415342-90e1-411b-b6c9-652e9532c6112
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD8007a226-f0d2-4618-af13-33c807f36ab52
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCDbd415342-90e1-411b-b6c9-652e9532c6112
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY8007a226-f0d2-4618-af13-33c807f36ab52
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSYbd415342-90e1-411b-b6c9-652e9532c6112
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY8007a226-f0d2-4618-af13-33c807f36ab52
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSYbd415342-90e1-411b-b6c9-652e9532c6112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-433-21458020433211 BOTTLE in 1 CARTON (45802-433-21) / 89 mL in 1 BOTTLE1 bottle2012-09-100000-00-00NoNoCurrent