FDA.reportPublic FDA data

Naproxen

Product NDC
66267-153
11-digit product format
662670153
Labeler code
66267
Product ID
66267-153_1f98cfb6-fa4d-2288-e063-6294a90a4de7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-153-15557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-153-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-153-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-153-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-153-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-153-42557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-153-14557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-153-40557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-153-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-153-158af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-153-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-153-908af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-153-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-153-108af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-153-428af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-153-148af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-153-408af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-153-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-153-15834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-153-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-153-90834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-153-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-153-10834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-153-42834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-153-14834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-153-40834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-153-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-153-151332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-153-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-153-901332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-153-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-153-101332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-153-421332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-153-141332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-153-401332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-153-201332a3947898…d4bfe170f9cd…

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
A078250-001NAPROXENNAPROXEN250MGTABLET / ORALAB2007-03-28
A078250-002NAPROXENNAPROXEN375MGTABLET / ORALAB2007-03-28
A078250-003NAPROXENNAPROXEN500MGTABLET / ORALAB2007-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078250-001AB
A078250-002AB
A078250-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-2884e616aacf4f…
2026-09-14 22:38:342026-08A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-2884e616aacf4f…
2026-09-14 22:38:342026-08A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078250-002NAPROXEN375MGTABLET / ORALAB2007-03-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078250-003NAPROXEN500MGTABLET / ORALAB2007-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078250-001NAPROXEN250MGTABLET / ORALAB2007-03-28301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078250-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078250-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078250-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078250-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078250-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078250-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078250-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078250-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078250-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078250-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078250-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078250-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078250-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078250-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078250-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078250-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078250-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078250-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078250-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078250-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078250-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078250-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078250-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078250-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078250-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078250-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078250-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078250-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078250-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078250-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078250-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078250-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078250-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078250-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078250-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078250-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078250-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078250-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078250-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078250-001AB1301d65b070ca…

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
Naproxen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
57Y76R9ATQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198014Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e8bcc59-dab1-1b4c-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
66267-153-102024-08-13NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-142024-08-13NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-152024-08-13NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-202024-08-13NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-302024-08-13NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-402024-08-13NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-422024-08-13NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-602024-08-13NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-902024-08-13NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-102023-01-30NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-142023-01-30NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-152023-01-30NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-202023-01-30NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-302023-01-30NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-402023-01-30NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-422023-01-30NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-602023-01-30NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-902023-01-30NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-153-10Naproxen10 in 1 BOTTLETABLET105
66267-153-14Naproxen14 in 1 BOTTLETABLET145
66267-153-15Naproxen15 in 1 BOTTLETABLET155
66267-153-20Naproxen20 in 1 BOTTLETABLET205
66267-153-30Naproxen30 in 1 BOTTLETABLET305
66267-153-40Naproxen40 in 1 BOTTLETABLET405
66267-153-42Naproxen42 in 1 BOTTLETABLET425
66267-153-60Naproxen60 in 1 BOTTLETABLET605
66267-153-90Naproxen90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-153-10EA - Each66267-153e1b54eb1-cc6f-4eef-832b-402dee6ae72012016-11-08
66267-153-14EA - Each66267-15345260482-ba3c-4007-b9c1-6e2e78c8656f12016-11-08
66267-153-15EA - Each66267-153dcf43333-4700-44bb-b069-2f77b7cb375b12016-11-08
66267-153-20EA - Each66267-1532f5e2585-7984-41d9-86c8-e8955355c92812016-11-08
66267-153-30EA - Each66267-153f73ad854-725b-43c6-a708-92415c90bed212016-11-08
66267-153-40EA - Each66267-153baeae0cb-52b2-4e5f-ae70-455f23cb7d8912016-11-08
66267-153-42EA - Each66267-1535bd91c31-eadc-417d-9633-7dd73104478412016-11-08
66267-153-60EA - Each66267-15317fdbbb7-8d7c-4377-800c-a4fdc5e6c66c12016-11-08
66267-153-90EA - Each66267-153f3dc0cd9-38a2-4a32-adbd-d0f1fc7955b412016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-153NAPROXEN TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 9 package rows20240815_3e8bcc59-dab1-1b4c-e054-00144ff88e88.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENProficient Rx LP96601d76-50ea-4dc0-b588-d174f8d8bb512022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078250
application number: ANDA078250
NaproxenNAPROXENProficient Rx LP3e4e5371-d796-47c7-95c1-d99e82a0b2822021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078250
application number: ANDA078250
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLC3e14f839-d1e4-44df-a457-29f005b3e62e2020-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078250
application number: ANDA078250

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN3e8bcc59-dab1-1b4c-e054-00144ff88e885
198014naproxen 500 MG Oral TabletSCD3e8bcc59-dab1-1b4c-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-153-106626701531010 TABLET in 1 BOTTLE (66267-153-10) 10 tablet2016-10-100000-00-00NoNoCurrent
66267-153-146626701531414 TABLET in 1 BOTTLE (66267-153-14) 14 tablet2016-10-100000-00-00NoNoCurrent
66267-153-156626701531515 TABLET in 1 BOTTLE (66267-153-15) 15 tablet2016-10-100000-00-00NoNoCurrent
66267-153-206626701532020 TABLET in 1 BOTTLE (66267-153-20) 20 tablet2016-10-100000-00-00NoNoCurrent
66267-153-306626701533030 TABLET in 1 BOTTLE (66267-153-30) 30 tablet2016-10-100000-00-00NoNoCurrent
66267-153-406626701534040 TABLET in 1 BOTTLE (66267-153-40) 40 tablet2016-10-100000-00-00NoNoCurrent
66267-153-426626701534242 TABLET in 1 BOTTLE (66267-153-42) 42 tablet2016-10-100000-00-00NoNoCurrent
66267-153-606626701536060 TABLET in 1 BOTTLE (66267-153-60) 60 tablet2016-10-100000-00-00NoNoCurrent
66267-153-906626701539090 TABLET in 1 BOTTLE (66267-153-90) 90 tablet2016-10-100000-00-00NoNoCurrent