FDA.reportPublic FDA data

Sprintec

Product NDC
0555-9016
11-digit product format
005559016
Labeler code
0555
Product ID
0555-9016_a12a68e8-a8fe-4ce5-aa31-b3366c470150
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norgestimate and Ethinyl Estradiol
Dosage form
KIT
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075804
Marketing category
ANDA
Marketing start
2002-09-26
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sprintec
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui240128, 748797, 749860, 753481

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11Product name420250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
1a545a57-aed5-4b6e-b1f9-a93c26d50effProduct name120230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9Product name820200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
60ff9adc-7870-42ca-8836-514bd9732fa8Product name420181220
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
2d386545-84d1-e1e9-1402-7fc8962353e8Product name220170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8Product name420170608
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-9016-58Sprintec1 in 1 POUCHKIT113
0555-9016-58Sprintec6 in 1 CARTONKIT613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9016-58EA - Each0555-90161cfa011e-f82a-4703-81b3-1fd1ccdcd99712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571USPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571USPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
NORGESTIMATEACTIVE MOIETYC291HFX4DYSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
ALUMINUM CHLORIDEINACTIVE INGREDIENT3CYT62D3GASPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
AMMONIUM SULFATEINACTIVE INGREDIENTSU46BAM238SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBUSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571USPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571USPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
NORGESTIMATEACTIVE MOIETYC291HFX4DYSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9016SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]13Current NDC, Legacy NDC, 2 package rows20250130_d9252820-131a-4870-8b11-945d1bfd5659.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753481{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Sprintec 28 Day]BPCKd9252820-131a-4870-8b11-945d1bfd565913
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKd9252820-131a-4870-8b11-945d1bfd565913
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNd9252820-131a-4870-8b11-945d1bfd565913
748797inert 1 MG Oral TabletPSNd9252820-131a-4870-8b11-945d1bfd565913
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSNd9252820-131a-4870-8b11-945d1bfd565913
753481Sprintec 28 Day PackPSNd9252820-131a-4870-8b11-945d1bfd565913
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCDd9252820-131a-4870-8b11-945d1bfd565913
748797inert ingredients 1 MG Oral TabletSCDd9252820-131a-4870-8b11-945d1bfd565913
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSYd9252820-131a-4870-8b11-945d1bfd565913
753481Sprintec 28 Day PackSYd9252820-131a-4870-8b11-945d1bfd565913
753481{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Sprintec 28 Day]BPCK90240210-0bca-4a55-99dc-19f2b40d8e3f8
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK00dd9b78-dd90-414b-b241-7619aa9d1ed28
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK90240210-0bca-4a55-99dc-19f2b40d8e3f8
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN00dd9b78-dd90-414b-b241-7619aa9d1ed28
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN90240210-0bca-4a55-99dc-19f2b40d8e3f8
748797inert 1 MG Oral TabletPSN90240210-0bca-4a55-99dc-19f2b40d8e3f8
748797inert 1 MG Oral TabletPSN00dd9b78-dd90-414b-b241-7619aa9d1ed28
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN00dd9b78-dd90-414b-b241-7619aa9d1ed28
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN90240210-0bca-4a55-99dc-19f2b40d8e3f8
753481Sprintec 28 Day PackPSN90240210-0bca-4a55-99dc-19f2b40d8e3f8
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD90240210-0bca-4a55-99dc-19f2b40d8e3f8
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD00dd9b78-dd90-414b-b241-7619aa9d1ed28
748797inert ingredients 1 MG Oral TabletSCD00dd9b78-dd90-414b-b241-7619aa9d1ed28
748797inert ingredients 1 MG Oral TabletSCD90240210-0bca-4a55-99dc-19f2b40d8e3f8
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY00dd9b78-dd90-414b-b241-7619aa9d1ed28
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY90240210-0bca-4a55-99dc-19f2b40d8e3f8
753481Sprintec 28 Day PackSY90240210-0bca-4a55-99dc-19f2b40d8e3f8
753481{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Sprintec 28 Day]BPCK4e1927bd-378d-45dc-8b18-3dd57ccd2cb65
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK4e1927bd-378d-45dc-8b18-3dd57ccd2cb65
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN4e1927bd-378d-45dc-8b18-3dd57ccd2cb65
748797inert 1 MG Oral TabletPSN4e1927bd-378d-45dc-8b18-3dd57ccd2cb65
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN4e1927bd-378d-45dc-8b18-3dd57ccd2cb65
753481Sprintec 28 Day PackPSN4e1927bd-378d-45dc-8b18-3dd57ccd2cb65
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD4e1927bd-378d-45dc-8b18-3dd57ccd2cb65
748797inert ingredients 1 MG Oral TabletSCD4e1927bd-378d-45dc-8b18-3dd57ccd2cb65
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY4e1927bd-378d-45dc-8b18-3dd57ccd2cb65
753481Sprintec 28 Day PackSY4e1927bd-378d-45dc-8b18-3dd57ccd2cb65
753481{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Sprintec 28 Day]BPCKe2f5ed4f-dd97-4dda-83d1-f8edd8786c0e1
753481{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Sprintec 28 Day]BPCK1cfc748b-2b54-6a6c-e063-6294a90a29301
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKe2f5ed4f-dd97-4dda-83d1-f8edd8786c0e1
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK1cfc748b-2b54-6a6c-e063-6294a90a29301
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNe2f5ed4f-dd97-4dda-83d1-f8edd8786c0e1
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN1cfc748b-2b54-6a6c-e063-6294a90a29301
748797inert 1 MG Oral TabletPSNe2f5ed4f-dd97-4dda-83d1-f8edd8786c0e1
748797inert 1 MG Oral TabletPSN1cfc748b-2b54-6a6c-e063-6294a90a29301
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN1cfc748b-2b54-6a6c-e063-6294a90a29301
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSNe2f5ed4f-dd97-4dda-83d1-f8edd8786c0e1
753481Sprintec 28 Day PackPSNe2f5ed4f-dd97-4dda-83d1-f8edd8786c0e1
753481Sprintec 28 Day PackPSN1cfc748b-2b54-6a6c-e063-6294a90a29301
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCDe2f5ed4f-dd97-4dda-83d1-f8edd8786c0e1
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD1cfc748b-2b54-6a6c-e063-6294a90a29301
748797inert ingredients 1 MG Oral TabletSCDe2f5ed4f-dd97-4dda-83d1-f8edd8786c0e1
748797inert ingredients 1 MG Oral TabletSCD1cfc748b-2b54-6a6c-e063-6294a90a29301
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY1cfc748b-2b54-6a6c-e063-6294a90a29301
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSYe2f5ed4f-dd97-4dda-83d1-f8edd8786c0e1
753481Sprintec 28 Day PackSYe2f5ed4f-dd97-4dda-83d1-f8edd8786c0e1
753481Sprintec 28 Day PackSY1cfc748b-2b54-6a6c-e063-6294a90a29301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-9016-58005559016586 POUCH in 1 CARTON (0555-9016-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK6 pouch2002-09-260000-00-00NoNoCurrent